Home › NDC Lookup › Ingredients › Zinc Oxide › 59088-0563-01

DermacinRx Zinc Oxide Skin Healing 200 mg/g Paste, 4 g

by PureTek Corporation · 4 g in 1 PACKET (59088-563-01)

NDC 59088-0563-01

🏷️ FDA NDC (as labeled) 59088-563-01 billing pads the product segment with a zero

OTC On market Non-controlled

🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026

Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026

Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026

Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026

Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026

Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 59088-563-01

Product NDC 59088-563

11-digit billing NDC 59088056301

RxCUI 416684

UNII SOI2LOH54Z

UPC 0359088563014

Application # M016

SPL Set ID c47f8a9c-9c86-4068-814e-05ab2090d19e

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2016-08-03

Route TOPICAL

Dosage form PASTE

Substance ZINC OXIDE

Why two NDCs? The FDA registers this code as 59088-563-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59088-0563-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerPureTek Corporation

FDA applicationM016 (OTC MONOGRAPH DRUG)

Labeler code59088

First marketedAug 2016

Product typeHuman Otc Drug

Portfolio178 products on file

🔎 All NDCs from PureTek Corporation

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter topical paste containing zinc oxide at a concentration of 200 mg per gram. Zinc oxide is commonly used in skin care products to form a protective barrier on the skin surface and is typically applied to areas needing soothing or protective effects. As an OTC monograph drug, this product is marketed under FDA's established rules for its category rather than through individual product approval.

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor

🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

From the label’s inactive-ingredient sectionAleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil, Fragrance, Maltodextrin, Modified Corn Starch, Niacinamide (Vitamin B3), Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petrolatum, Phenoxyethanol, Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E), Zingiber Officinale (Ginger) Root Extract.

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per g	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Leader Zinc Oxide 200 mg/g 70000-0334-01	Cardinal	454 g	$0.016	—	Availability likely	—
Nivagen Zinc Oxide 200 mg/g 75834-0170-01	Nivagen	28.4 g	$0.107	—	Availability likely	—
Critic Aid Skin 200 mg/g 11701-0050-32	Coloplast	170 g	—	—	FDA listed	—
Medline 200 mg/g 53329-0255-05	Medline	170 g	—	—	FDA listed	—
DermacinRx Zinc Oxide Skin Healing 200 mg/gthis 59088-0563-01	PureTek	4 g	—	—	FDA listed	—
Zinctral 20 g/100g 59088-0627-05	PureTek	57 g	—	—	FDA listed	—
Sheffield Zinc Oxide 200 mg/g 11527-0065-34	Sheffield	1 tube	—	—	FDA listed	—
Mineral Body Sunscreen Unscented 200 mg/g 69949-0111-01	Synchronicity	85 g	—	—	FDA listed	—
Shunly Zn20 Light Moisturizer 200 mg/g 81381-0205-04	Shunly	113 g	—	—	FDA listed	—
Zinc Oxide Pharma 200 mg/g 84387-0001-01	ALLIED	56.6 g	—	—	FDA listed	—
Skin Tone Defender 20% Zinc Oxide 200 mg/g 85298-0205-04	Cali	115 g	—	—	FDA listed	—
Protect 20 Zinc Oxide Mineral Sunscreen Tinted 200 mg/g 85314-0204-60	Melinda	60 g	—	—	FDA listed	—
Protect 20 Zinc Oxide Mineral Sunscreen Non-Tinted 200 mg/g 85314-0205-04	Melinda	113 g	—	—	FDA listed	—
Sol Purpose Mineral Sunscreen Tinted 200 mg/g 85317-0204-60	TRU	60 g	—	—	FDA listed	—
Sheer Mineral Sunscreen Satin Dewy Finish 200 mg/g 85317-0205-04	TRU	113 g	—	—	FDA listed	—
Covered 200 mg/g 85319-0205-15	Potency	1.5 g	—	—	FDA listed	—
SPF 40 Broad Spectrum Non-Tinted 200 mg/g 85339-0205-04	Teton	113 g	—	—	FDA listed	—
Hydrating Mineral Zinc Oxide SPF 40 200 mg/g 85360-0205-04	Spalina	113 g	—	—	FDA listed	—
Glass Skin Sunscreen Tinted 200 mg/g 85428-0204-15	Fleur	1.5 g	—	—	FDA listed	—
Hiya Kids SPF 40 Mineral Sunscren 200 mg/g 85447-0001-01	Hiya	65 g	—	—	FDA listed	—
Non Tinted Mineral Sunscreen 200 mg/g 85460-0205-04	Micro	113 g	—	—	FDA listed	—
ProtectME Tinted Mineral SPF 40 20% 200 mg/g 85470-0204-60	PUREFECTION	60 g	—	—	FDA listed	—
Skin Filter Glow SPF 200 mg/g 85496-0204-60	MALORIE	60 g	—	—	FDA listed	—
Chem-Free Sunscreen Non-Tinted Formula 200 mg/g 85507-0205-04	IT	113 g	—	—	FDA listed	—
Simply Zinc Mineral Sunscreen Tinted 200 mg/g 85519-0204-60	SKIN	60 g	—	—	FDA listed	—
Gentle Defense Sunscreen 200 mg/g 85533-0205-15	Mint	1.5 g	—	—	FDA listed	—
Moisturizing Mineral Sunscreen Tinted 200 mg/g 85558-0204-60	LOTUS	60 g	—	—	FDA listed	—
Sacred Aura 200 mg/g 85583-0205-04	IRIA	113 g	—	—	FDA listed	—
Mineral Sunscreen 200 mg/g 85645-0205-15	LEILANI	1.5 g	—	—	FDA listed	—
Non Tinted Mineral Sunscreen 20Percent Zinc Oxide 200 mg/g 85672-0205-04	JKH	113 g	—	—	FDA listed	—
Mineral Sunscreen Tinted Zinc Oxide 200 mg/g 85727-0204-60	KS	60 g	—	—	FDA listed	—
Stay Shady Non-Tinted Mineral Sunscreen 200 mg/g 85969-0205-15	AMOIE	1.5 g	—	—	FDA listed	—
CoTZ Kids 200 mg/g 58892-0619-05	Fallien	5 g	—	—	FDA listed	—
THERA Calazinc Body Shield 200 mg/g 68599-0205-01	McKesson	144 packets	—	—	FDA listed	—
NATURAL MOISTURIZING FACE SUNSCREEN and PRIMER 200 mg/g 69949-0010-01	Synchronicity	50 g	—	—	FDA listed	—
5-In-1 Tinted Face Sunscreen - Golden Light 200 mg/g 69949-0053-01	Synchronicity	56.7 g	—	—	FDA listed	—
SPF 50 Sunscreen Stick 200 mg/g 79747-0004-01	ELEEO	14 g	—	—	FDA listed	—
Daily Moisturizing Glow Sunscreen Cream 200 mg/g 85326-0205-04	Shelley	113 g	—	—	FDA listed	—
Tinted Mineral Sunscreen 200 mg/g 85366-0204-60	Gentlehomme	60 g	—	—	FDA listed	—
non-tinted face and body mineral sunscreen SPF40 200 mg/g 85370-0205-04	Lisa	113 g	—	—	FDA listed	—
The Block 200 mg/g 85444-0204-60	ELITE	60 g	—	—	FDA listed	—
Tinted Mineral Sunscreen 200 mg/g 85469-0204-60	JMSE	60 g	—	—	FDA listed	—
Tinted Mineral Sunscreen Cream 200 mg/g 85554-0204-60	ESTILO	60 g	—	—	FDA listed	—
Sheer Mineral Face And Body Sunscreen Tinted 200 mg/g 85596-0204-60	LAURA	60 g	—	—	FDA listed	—
20 Zinc Oxide Tinted Mineral Sunscreen 200 mg/g 85621-0204-60	AGELESS	60 g	—	—	FDA listed	—
Tinted Ultra Zinc Face and Body 200 mg/g 85698-0204-60	LIV	60 g	—	—	FDA listed	—
Non Tinted Ultra Zinc Face and Body 200 mg/g 85698-0205-04	LIV	113 g	—	—	FDA listed	—
Daily Shade Sheer Matte 200 mg/g 85712-0205-04	BLISS	113 g	—	—	FDA listed	—
Not YO 80s Zinc Sunscreen 200 mg/g 85752-0205-15	CLEAN	15 g	—	—	FDA listed	—
Hint of Tint 200 mg/g 85768-0204-15	L.S.	1.5 g	—	—	FDA listed	—
Total Body Block Sunscreen 200 mg/g 85861-0205-15	ADR	1.5 g	—	—	FDA listed	—
Solar Shield Face and Body SPF 40 200 mg/g 85944-0205-04	BRIGHT	113 g	—	—	FDA listed	—
Tinted Mineral Sunscreen 200 mg/g 87122-0204-60	MADRE	60 g	—	—	FDA listed	—
Sun Defense Mineral Sunscreen SPF 30 Face 200 mg/g 54108-0420-01	derma	1 tube	—	—	FDA listed	—
CoTZ Flawless Complexion 200 mg/g 58892-0170-50	Fallien	1 tube	—	—	FDA listed	—
Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxide 200 mg/g 58892-0204-50	Fallien	60 g	—	—	FDA listed	—
CVS Zinc Oxide 200 mg/g 69842-0065-34	CVS	1 tube	—	—	FDA listed	—
Natural Mineral Body Sunscreen 200 mg/g 69949-0100-01	Synchronicity	85 g	—	—	FDA listed	—
Healthy Mineral Sunscreen Brightening plus Tint 200 mg/g 85338-0204-60	ZEN	60 g	—	—	FDA listed	—
Sun Therapy Sunscreen 200 mg/g 85357-0204-60	Skin	60 g	—	—	FDA listed	—
Z Bloc 200 mg/g 85394-0205-04	The	113 g	—	—	FDA listed	—
Daily Skin Protection Sunscreen NT 200 mg/g 85479-0205-04	SKINPLUSBYOROYO	113 g	—	—	FDA listed	—
Deflectin Tinted Mineral Sunscreen 200 mg/g 85497-0204-60	AEON	60 g	—	—	FDA listed	—
Ultra Zinc Physical Defense 200 mg/g 85499-0205-04	ATLANTA	113 g	—	—	FDA listed	—
Color Smart Tinted Mineral 200 mg/g 85560-0204-60	MEGAN	60 g	—	—	FDA listed	—
Tinted Moisturizing Mineral Sunscreen 200 mg/g 85642-0204-60	EDIT	60 g	—	—	FDA listed	—
Mineral Sunscreen Face plus Body 200 mg/g 85727-0205-04	KS	113 g	—	—	FDA listed	—
Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40 200 mg/g 85747-0205-04	WECARE	113 g	—	—	FDA listed	—
Daily Protect Tinted Mineral Sunscreen 200 mg/g 87199-0204-15	SARAH'S	1.5 g	—	—	FDA listed	—
Baby Mineral Sunscreen SPF55 200 mg/g 73418-0100-03	Hello	85.05 g	—	—	FDA listed	—
Zinc Oxide SPF 40 Non-Tinted 200 mg/g 85296-0205-04	Skin	113 g	—	—	FDA listed	—
Mineral Sunscreen For Face and Body 200 mg/g 85330-0205-04	Skin	113 g	—	—	FDA listed	—
Ultra Zinc Mineral Non Tinted 200 mg/g 85357-0205-04	Skin	113 g	—	—	FDA listed	—
Mineral Sunscreen Non-Tinted 200 mg/g 85372-0205-04	Glow	113 g	—	—	FDA listed	—
face Plus body sunscreen non-tinted 200 mg/g 85425-0205-04	Skin	113 g	—	—	FDA listed	—
Tinted Mineral Sunscreen 200 mg/g 85460-0204-60	Micro	60 g	—	—	FDA listed	—
Body-Screen 200 mg/g 85496-0205-04	MALORIE	113 g	—	—	FDA listed	—
Daytime Moisture SPF40 200 mg/g 85504-0204-60	COLETTE	60 g	—	—	FDA listed	—
Chem Free Sunscreen Tinted Formula 200 mg/g 85507-0204-60	IT	60 g	—	—	FDA listed	—
Non Tinted Mineral Sunscreen 20Percent Zinc Oxide 200 mg/g 85554-0205-04	ESTILO	113 g	—	—	FDA listed	—
Non - Tinted Mineral Sunscreen 200 mg/g 85575-0205-04	NEXTEX	113 g	—	—	FDA listed	—
Nourish And Defend 200 mg/g 85584-0204-60	ANASTASIA	60 g	—	—	FDA listed	—
20Percent Zinc Oxide Non Tinted 200 mg/g 85585-0205-15	JEFFREY	1.5 g	—	—	FDA listed	—
Royal Screen 200 mg/g 85616-0205-15	QUEENIES	15 g	—	—	FDA listed	—
Calming Protection SPF40 200 mg/g 85630-0205-04	FRESH	113 g	—	—	FDA listed	—
Tinted Sheer Mineral Zinc Sunscreen 200 mg/g 85887-0204-60	SKIN	60 g	—	—	FDA listed	—
Daily Protect Mineral Sunscreen 200 mg/g 87199-0205-04	SARAH'S	113 g	—	—	FDA listed	—
HEB SPF 50 Kids Purple Mineral Sunscreen Stick Grape Scented 200 mg/g 37808-0039-01	H.E.B.	13.3 g	—	—	FDA listed	—
TiZO Ultra Zinc SPF 40 (Tinted) 200 mg/g 58892-0319-01	Fallien	1 tube	—	—	FDA listed	—
TiZO ULTRA ZINC Non-Tinted SPF 40 MINERAL SUNSCREEN FOR BODY and FACE With Antioxidants C and E 200 mg/g 58892-0322-30	Fallien	30 g	—	—	FDA listed	—
CoTZ Baby 200 mg/g 58892-0618-01	Fallien	1 tube	—	—	FDA listed	—
Safeguard SPF 40 200 mg/g 83578-0205-35	Skinsalvation	100 g	—	—	FDA listed	—
Glow Shield Spf 200 mg/g 85291-0205-04	ACNE	113 g	—	—	FDA listed	—
Zinc Oxide SPF 40 Tinted 200 mg/g 85296-0204-60	Skin	60 g	—	—	FDA listed	—
Tinted Zinc Protection 200 mg/g 85339-0204-60	Teton	60 g	—	—	FDA listed	—
Prime And Protect Dewy 200 mg/g 85363-0204-60	Kalon	60 g	—	—	FDA listed	—
Non Tinted Mineral Sunscreen 200 mg/g 85395-0205-15	SPECKTRA6	1.5 g	—	—	FDA listed	—
Canopy Untinted 200 mg/g 85399-0205-04	BORREGO	113 g	—	—	FDA listed	—
Ultimate Physical Sunscreen Tinted 200 mg/g 85413-0204-60	HALEM	60 g	—	—	FDA listed	—
Solar Eclipse Extreme Sunscreen 200 mg/g 85491-0205-04	ULTRAVIOLET	113 g	—	—	FDA listed	—
Non-Tinted Zinc Body And Face SPF40 200 mg/g 85508-0205-15	RSL89	1.5 g	—	—	FDA listed	—
Moisturizing Face and Body SPF 200 mg/g 85552-0205-04	SKIN	113 g	—	—	FDA listed	—
Non Tinted Mineral Sunscreen 200 mg/g 85589-0205-04	Natur	113 g	—	—	FDA listed	—
Sheer Mineral Face And Body Sunscreen Non Tinted 200 mg/g 85596-0205-04	LAURA	113 g	—	—	FDA listed	—
Mermaid Glow And Go Non Tinted Mineral Sunscreen 200 mg/g 85647-0205-15	Mermaid	1.5 g	—	—	FDA listed	—
Simply Protected Tinted Mineral Sunscreen 200 mg/g 85726-0204-60	Healthy	60 g	—	—	FDA listed	—
Non-Tinted 20% Zinc Mineral Sunscreen 200 mg/g 85758-0205-04	BELLA	113 g	—	—	FDA listed	—
Eclipse Body Non Tinted 200 mg/g 85890-0205-04	DENISE	113 g	—	—	FDA listed	—
Kind Restore Tinted Mineral Sunscreen 200 mg/g 85895-0204-60	POLISH	60 g	—	—	FDA listed	—
Premier Zinc 200 mg/g 85971-0205-04	ENSO	113 g	—	—	FDA listed	—
TiZO Ultra Zinc SPF 40 (Non-Tinted) 200 mg/g 58892-0317-01	Fallien	1 tube	—	—	FDA listed	—
Thinkbaby Sunscreen SPF 30 200 mg/g 60781-2003-01	thinkOperations,LLC	18.4 g	—	—	FDA listed	—
Tinted Mineral Sunscreen 20% Zinc Oxide 200 mg/g 85306-0204-21	INTEGRATIVE	60 g	—	—	FDA listed	—
Florida Babe Active Non-Tinted 20percent Zinc Oxide Mineral Sunscreen 200 mg/g 85337-0205-04	Tichy	113 g	—	—	FDA listed	—
Healthy Mineral Sunscreen Face and Body 200 mg/g 85338-0205-04	Zen	113 g	—	—	FDA listed	—
MATTE Non Tinted Mineral Sunscreen 200 mg/g 85386-0205-04	Allure	113 g	—	—	FDA listed	—
Mineral Sunscreen Zinc Oxide 200 mg/g 85414-0205-04	Hirschman,	113 g	—	—	FDA listed	—
Glass Skin Sunscreen Non-Tinted 200 mg/g 85428-0205-04	Fleur	113 g	—	—	FDA listed	—
Ultra Sheer Sunscreen 200 mg/g 85462-0205-04	SKINBAR	113 g	—	—	FDA listed	—
Gentle Mineral SPF 40 Tinted 200 mg/g 85555-0204-60	ELIZA	60 g	—	—	FDA listed	—
Tinted Mineral Sunscreen 200 mg/g 85589-0204-60	Natur	60 g	—	—	FDA listed	—
Instant Glow 200 mg/g 85599-0205-15	CLEAN	1.5 g	—	—	FDA listed	—
Non Tinted Moisturizing Mineral Sunscreen 200 mg/g 85642-0205-04	EDIT	113 g	—	—	FDA listed	—
Face and Body Sunscreen 200 mg/g 85696-0205-04	SCIENCE	113 g	—	—	FDA listed	—
Non Tinted Sheer Mineral Zinc Sunscreen 200 mg/g 85887-0205-04	SKIN	113 g	—	—	FDA listed	—
Eclipse Face Tinted 200 mg/g 85890-0204-60	DENISE	60 g	—	—	FDA listed	—
Mineral Sunscreen 20percent Zinc Oxide 200 mg/g 85987-0205-04	ESTHETICS	113 g	—	—	FDA listed	—
Bella Blue Skin Care Tinted Sunscreen 200 mg/g 87099-0204-60	BELLA	60 g	—	—	FDA listed	—
Dermatone SPF 50 Sunscreen Stick 200 mg/g 54414-0108-01	Dermatone	14 g	—	—	FDA listed	—
Daily Mineral Sunscreen 20% Zinc Oxide 200 mg/g 85306-0205-40	INTEGRATIVE	113 g	—	—	FDA listed	—
3-in-1 Daily Vanishing Tinted Sunscreen Cream 200 mg/g 85326-0204-60	Shelley	60 g	—	—	FDA listed	—
20Percent Zinc Oxide Sunscreen 200 mg/g 85364-0205-04	Minder	113 g	—	—	FDA listed	—
Zinc 20 mineral sunscreen face Plus body 200 mg/g 85367-0205-15	PURE	1.5 g	—	—	FDA listed	—
Tinted Mineral Sunscreen 200 mg/g 85375-0204-60	KLOE	60 g	—	—	FDA listed	—
Mineral Sunscreen 20percent Zinc Oxide 200 mg/g 85377-0205-04	Mantra	113 g	—	—	FDA listed	—
GLOW Tinted Mineral Sunscreen 200 mg/g 85386-0204-60	Allure	60 g	—	—	FDA listed	—
The Tinted Mineral Sunscreen 200 mg/g 85412-0204-60	The	60 g	—	—	FDA listed	—
Protect ME Non Tinted Mineral SPF 40 200 mg/g 85470-0205-04	PUREFECTION	113 g	—	—	FDA listed	—
Non Tinted Mineral Moisturizing Sunscreen 200 mg/g 85490-0205-04	ABOUT	113 g	—	—	FDA listed	—
Zinc 20Percent SPF 40 200 mg/g 85531-0205-04	JOHANNA'S	113 g	—	—	FDA listed	—
Cotz Sensitive SPF 40 Sunscreen 200 mg/g 58892-0418-01	Fallien	1 tube	—	—	FDA listed	—
Thinksport SPF 30 200 mg/g 60781-4487-01	thinkOperations,LLC	1 applicator	—	—	FDA listed	—
5-In-1 Tinted Face Sunscreen - Light 200 mg/g 69949-0052-01	Synchronicity	56.7 g	—	—	FDA listed	—
SPF 50 Sunscreen Stick 200 mg/g 84061-0129-01	Australian	14 g	—	—	FDA listed	—
Florida Babe Active Tinted 20percent Zinc Oxide Mineral Sunscreen 200 mg/g 85337-0204-60	Tichy	60 g	—	—	FDA listed	—
tinted face and body mineral sunscreen SPF40 200 mg/g 85370-0204-60	Lisa	60 g	—	—	FDA listed	—
Extreme Protection Non Tinted 200 mg/g 85403-0205-15	BIOHEALTH	1.5 g	—	—	FDA listed	—
Prevention Body 200 mg/g 85404-0205-15	NY	1.5 g	—	—	FDA listed	—
Ultimate Physical Sunscreen 200 mg/g 85413-0205-04	HALEM	113 g	—	—	FDA listed	—
Oil Free Anti-Aging 200 mg/g 85466-0204-60	DERMOPERFECTION	60 g	—	—	FDA listed	—
20 Zinc Oxide Non-Tinted Mineral Sunscreen 200 mg/g 85621-0205-04	AGELESS	113 g	—	—	FDA listed	—
Ultra UV Shade tinted moisturizing mineral SPF 40 200 mg/g 85632-0204-60	Joyce	60 g	—	—	FDA listed	—
Ultra Solar Shield non-tinted moisturizing mineral SPF 40 200 mg/g 85632-0205-04	Joyce	113 g	—	—	FDA listed	—
Sunshade Mineral Sunscreen 200 mg/g 85730-0205-04	BELLAGENA	113 g	—	—	FDA listed	—
Non-Tinted Mineral Sunscreen 200 mg/g 85805-0205-04	OLGA	113 g	—	—	FDA listed	—
Bella Blu Skin Care Non Tinted Sunscreen 200 mg/g 87099-0205-15	BELLA	1.5 g	—	—	FDA listed	—
Dew Mineral 200 mg/g 87197-0204-60	ADVANCED	60 g	—	—	FDA listed	—
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry Scented 200 mg/g 37808-0000-01	H.E.B.	13.3 g	—	—	FDA listed	—
SPF 50 Sunscreen Stick 200 mg/g 63645-0178-05	OraLabs	14 g	—	—	FDA listed	—
Mineral Based Facial Sunscreen 200 mg/g 81679-0205-04	KATHLEEN	113 g	—	—	FDA listed	—
Clove Hill acne safe mineral sunscreen SPF 40 200 mg/g 82746-0205-04	Clove	115 g	—	—	FDA listed	—
Skin Apeel Pure Protect SPF 40 Broad Spectrum 200 mg/g 83628-0205-40	Skin	113 g	—	—	FDA listed	—
Signature Tint SPF 40 200 mg/g 85325-0204-60	ADVANCED	60 g	—	—	FDA listed	—
Tinted Mineral Sunscreen Zinc Oxide 200 mg/g 85414-0204-60	Hirschman,	60 g	—	—	FDA listed	—
face Plus body sunscreen tinted 200 mg/g 85425-0204-60	Skin	60 g	—	—	FDA listed	—
Advanced Mineral Sunscreen 200 mg/g 85452-0205-04	Charisma	113 g	—	—	FDA listed	—
Glow Shield 200 mg/g 85516-0204-60	Kristina	60 g	—	—	FDA listed	—
20Percent Zinc Total Protection 200 mg/g 85563-0205-04	CLEAR	113 g	—	—	FDA listed	—
Ultimate Mineral Protection 200 mg/g 85715-0205-04	MARK	113 g	—	—	FDA listed	—
Ageless All Fitz 200 mg/g 85736-0204-60	A.Wall	60 g	—	—	FDA listed	—
Yoali SPF 40 200 mg/g 85773-0204-60	YOALI	60 g	—	—	FDA listed	—
Aura Defense 200 mg/g 87271-0204-60	Grace	60 g	—	—	FDA listed	—
Endit zinc oxide skin protection 200 mg/g 64068-0500-01	EndIt	56.7 g	—	—	FDA listed	—
5-In-1 Tinted Face Sunscreen - Fair 200 mg/g 69949-0051-01	Synchronicity	56.7 g	—	—	FDA listed	—
5-In-1 Tinted Face Sunscreen - Medium 200 mg/g 69949-0054-01	Synchronicity	56.7 g	—	—	FDA listed	—
Tinted Mineral Sunscreen Broad Spectrum SPF 25 200 mg/g 72812-0152-01	Earth	84 g	—	—	FDA listed	—
Shunly Zn20 Tinted Light Moisturizer 200 mg/g 81381-0204-60	Shunly	60 g	—	—	FDA listed	—
True Tone Non Tinted 200 mg/g 85393-0205-04	That	113 g	—	—	FDA listed	—
Body Protect 200 mg/g 85463-0205-04	Noble	113 g	—	—	FDA listed	—
Luminous Tinted Moisturizing 200 mg/g 85503-0204-60	SKIN	60 g	—	—	FDA listed	—
Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxide 200 mg/g 58892-0205-04	Fallien	113 g	—	—	FDA listed	—
Baby Mineral Sunscreen Probiotics SPF55 200 mg/g 73418-0101-03	Hello	85.05 g	—	—	FDA listed	—
Mineral Sunscreen SPF 50 200 mg/g 73418-0102-05	Hello	141.75 g	—	—	FDA listed	—

About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2016

On the market since

Aug 2016

📍

2026

Currently FDA-listed

10 years listed

🔒

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
59088-0563-01 You're viewing this	4 g in 1 PACKET (59088-563-01)	2016-08-03	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
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NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?

An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 59088-563-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 59088-0563-01, written without dashes as 59088056301. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 59088-0563-01, the first segment (59088) is the labeler code FDA assigned to PureTek Corporation; the middle segment (0563) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by PureTek Corporation. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

PureTek Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions ⚠️ Warnings 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📋 Description 💬 Information for Patients

🎯 Indications and Usage 125 words ▾

1 INDICATIONS AND USAGE Clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older. Clotrimazole and betamethasone dipropionate cream contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.

( 1 )

Uses for the treatment and/or prevention of diaper rash temporarily protects and helps relieve minor skin irritation and itching due to rashes

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Treatment of tinea corporis or tinea cruris: Apply a thin film of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for one week. Do not use more than 45 grams per week. Do not use with occlusive dressings.

If a patient shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Do not use longer than 2 weeks. Treatment of tinea pedis: Gently massage a sufficient amount of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for two weeks.

Do not use more than 45 grams per week. Do not use with occlusive dressings. If a patient shows no clinical improvement after 2 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.

Do not use longer than 4 weeks. Clotrimazole and betamethasone dipropionate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Tinea pedis: Apply a thin film to the affected skin areas twice a day for 2 weeks. ( 2 ) Tinea cruris and tinea corporis: Apply a thin film to the affected skin area twice a day for 1 week. ( 2 ) Clotrimazole and betamethasone dipropionate cream should not be used longer than 2 weeks in the treatment of tinea corporis or tinea cruris, and longer than 4 weeks in the treatment of tinea pedis.

( 2 ) Do not use with occlusive dressings unless directed by a physician. ( 2 ) Not for ophthalmic, oral or intravaginal use. ( 2 )

Directions cleanse skin with warm water and soap apply paste to area as needed for G-tubes, cleanse as above, apply thin layer and secure with drain sponge or product as directed

💊 Dosage Forms and Strengths 77 words ▾

3 DOSAGE FORMS AND STRENGTHS Cream, 1%/0.05% (base). Each gram of clotrimazole and betamethasone dipropionate cream, USP contains 10 mg of clotrimazole, USP and 0.64 mg of betamethasone dipropionate USP, (equivalent to 0.5 mg of betamethasone) in a white to off-white hydrophilic cream. Cream, 1%/0.05% (base) ( 3 ) Each gram of clotrimazole and betamethasone dipropionate cream, contains 10 mg of clotrimazole and 0.64 mg of betamethasone dipropionate, (equivalent to 0.5 mg of betamethasone) ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Clotrimazole and betamethasone dipropionate cream can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of the treatment. Risk factor(s) are: use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and young age. Modify use should HPA axis suppression develop.

( 5.1 , 8.4 ) Pediatric patients may be more susceptible to systemic toxicity. ( 5.1 , 8.4 ) The use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis is not recommended. ( 5.2 )

5.1Effects on Endocrine System Clotrimazole and betamethasone dipropionate cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Cushing’s syndrome and hyperglycemia may also occur due to the systemic effect of corticosteroids while on treatment.

Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure, and young age. Because of the potential for systemic corticosteroid effects, patients may need to be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a small trial, clotrimazole and betamethasone dipropionate cream was applied using large dosages, 7 g daily for 14 days (twice a day) to the crural area of normal adult subjects. Three of the 8 normal subjects on whom clotrimazole and betamethasone dipropionate cream was applied exhibited low morning plasma cortisol levels during treatment. One of these subjects had an abnormal cosyntropin test.

The effect on morning plasma cortisol was transient and subjects recovered 1 week after discontinuing dosing. In addition, 2 separate trials in pediatric subjects demonstrated adrenal suppression as determined by cosyntropin testing [see Use in Specific Populations (8.4) ]. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin-surface-to-body mass ratios [see Use in Specific Populations (8.4) ].

5.2Diaper Dermatitis The use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis is not recommended.

⚠️ Warnings 70 words ▾

Warnings For external use only Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of childern. If swallowed, get medical help or contact a Poison Control Center right away.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions reported for clotrimazole and betamethasone dipropionate cream were paraesthesia in 1.9% of patients and rash, edema, and secondary infections each in less than 1% of patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials common adverse reaction reported for clotrimazole and betamethasone dipropionate cream was paresthesia in 1.9% of patients. Adverse reactions reported at a frequency less than 1% included rash, edema, and secondary infection.

6.2Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following local adverse reactions have been reported with topical corticosteroids: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, skin atrophy, striae, miliaria, capillary fragility (ecchymoses), telangiectasia, and sensitization (local reactions upon repeated application of product).

Adverse reactions reported with the use of clotrimazole are: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies with clotrimazole and betamethasone dipropionate cream in pregnant women. Therefore, clotrimazole and betamethasone dipropionate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate.

Corticosteroids are generally teratogenic in laboratory animals when administered at relatively low dosage levels. Studies in pregnant rats with intravaginal doses up to 100 mg/kg (15 times the maximum human dose) revealed no evidence of fetotoxicity due to clotrimazole exposure. No increase in fetal malformations was noted in pregnant rats receiving oral (gastric tube) clotrimazole doses up to 100 mg/kg/day during gestation Days 6 to 15.

However, clotrimazole dosed at 100 mg/kg/day was embryotoxic (increased resorptions), fetotoxic (reduced fetal weights), and maternally toxic (reduced body weight gain) to rats. Clotrimazole dosed at 200 mg/kg/day (30 times the maximum human dose) was maternally lethal, and therefore, fetuses were not evaluated in this group. Also in this study, doses up to 50 mg/kg/day (8 times the maximum human dose) had no adverse effects on dams or fetuses.

However, in the combined fertility, teratogenicity, and postnatal development study described above, 50 mg/kg clotrimazole was associated with reduced maternal weight gain and reduced numbers of offspring reared to 4 weeks. Oral clotrimazole doses of 25, 50, 100, and 200 mg/kg/day (2 to 15 times the maximum human dose) were not teratogenic in mice. No evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally with 60, 120, or 180 mg/kg/day (18 to 55 times the maximum human dose).

Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately one-fifth the maximum human dose. The abnormalities observed included umbilical hernias, cephalocele, and cleft palates.

Betamethasone dipropionate has not been tested for teratogenic potential by the dermal route of administration. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

8.3Nursing Mothers Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when clotrimazole and betamethasone dipropionate cream is administered to a nursing woman.

8.4Pediatric Use The use of clotrimazole and betamethasone dipropionate cream in patients under 17 years of age is not recommended. Adverse events consistent with corticosteroid use have been observed in pediatric patients treated with clotrimazole and betamethasone dipropionate cream. In open-label trials, 17 of 43 (39.5%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing.

In another open-label trial, 8 of 17 (47.1%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea cruris demonstrated adrenal suppression as determined by cosyntropin testing. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are, therefore also at greater risk of adrenal insufficiency during and/o…

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use ~1 min read ▾

Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids [see Warnings and Precautions (5.1) ]. Avoid use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis.

🧓 Geriatric Use 102 words ▾

8.5Geriatric Use Clinical studies of clotrimazole and betamethasone dipropionate cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, greater sensitivity of some older individuals cannot be ruled out. The use of clotrimazole and betamethasone dipropionate cream under occlusion, such as in diaper dermatitis, is not recommended.

Postmarket adverse event reporting for clotrimazole and betamethasone dipropionate cream in patients aged 65 and above includes reports of skin atrophy and rare reports of skin ulceration. Caution should be exercised with the use of these corticosteroid-containing topical products on thinning skin.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Clotrimazole is an azole antifungal [see Clinical Pharmacology (12.4) ]. Betamethasone dipropionate is a corticosteroid. Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action for the treatment of tinea pedis, tinea cruris and tinea corporis is unknown.

12.2Pharmacodynamics Vasoconstrictor Assay Studies performed with clotrimazole and betamethasone dipropionate cream indicate that these topical combination antifungal/corticosteroids may have vasoconstrictor potencies in a range that is comparable to high-potency topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

12.3Pharmacokinetics Skin penetration and systemic absorption of clotrimazole and betamethasone dipropionate following topical application of clotrimazole and betamethasone dipropionate cream has not been studied. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin.

Inflammation and/or other disease processes in the skin may increase percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [see Dosage and Administration (2) ] . Once absorbed through the skin, the pharmacokinetics of topical corticosteroids are similar to systemically administered corticosteroids.

Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

12.4Microbiology Mechanism of Action Clotrimazole, an azole antifungal agent, inhibits 14-α-demethylation of lanosterol in fungi by binding to one of the cytochrome P-450 enzymes. This leads to the accumulation of 14-α-methylsterols and reduced concentrations of ergosterol, a sterol essential for a normal fungal cytoplasmic membrane. The methylsterols may affect the electron transport system, thereby inhibiting growth of fungi.

Activity In Vitro and In Vivo Clotrimazole has been shown to be active against most strains of the following dermatophytes, both in vitro and in clinical infections, Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum [see Indications and Usage (1) ]. Drug Resistance Strains of dermatophytes having a natural resistance to clotrimazole have not been reported. Resistance to azoles, including clotrimazole, has been reported in some Candida species.

No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Trichophyton mentagrophytes.

🧬 Mechanism of Action 51 words ▾

📦 How Supplied / Storage and Handling 53 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Clotrimazole and betamethasone dipropionate cream, USP is available as follows: 15 gram tube in a carton (NDC 0472-0379-15) 45 gram tube in a carton (NDC 0472-0379-45) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

📦 Storage and Handling 8 words ▾

Other information protect from freezing avoid excessive heat

🧪 Active Ingredient 11 words ▾

Active ingredient Zinc Oxide 20.0% (3.0% as Calamine) Purpose Skin Protectant

🧪 Inactive Ingredients 63 words ▾

Inactive ingredients: Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil, Fragrance, Maltodextrin, Modified Corn Starch, Niacinamide (Vitamin B3), Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petrolatum, Phenoxyethanol, Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E), Zingiber Officinale (Ginger) Root Extract.

🎯 Purpose 3 words ▾

Purpose Skin Protectant

📋 Description 171 words ▾

11 DESCRIPTION Clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base), contains combinations of clotrimazole USP, an azole antifungal, and betamethasone dipropionate USP, a corticosteroid, for topical use. Chemically, clotrimazole, USP is 1-( o -Chloro-α,α-diphenylbenzyl)imidazole, with the molecular formula C 22 H 17 ClN 2 , a molecular weight of 344.84, and the following structural formula: Clotrimazole, USP is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate, USP has 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C 28 H 37 FO 7 , a molecular weight of 504.59, and the following structural formula: Betamethasone dipropionate, USP is a white to creamy-white, odorless crystalline powder, insoluble in water.

Each gram of clotrimazole and betamethasone dipropionate cream, USP contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a white to off-white hydrophilic cream. Inactive ingredients: Ceteareth-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic monohydrate, stearyl alcohol and white petrolatum; benzyl alcohol as preservative. image description image description

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling ( Patient Information ) Inform the patient of the following: Use clotrimazole and betamethasone dipropionate cream as directed by the physician. It is for external use only. Avoid contact with the eyes, the mouth, or intravaginally.

Do not use clotrimazole and betamethasone dipropionate cream on the face or underarms. Do not use more than 45 grams of clotrimazole and betamethasone dipropionate cream per week. When using clotrimazole and betamethasone dipropionate cream in the groin area, patients should use the medication for 2 weeks only, and apply the cream sparingly.

Patients should wear loose-fitting clothing. Notify the physician if the condition persists after 2 weeks. Do not use clotrimazole and betamethasone dipropionate cream for any disorder other than that for which it was prescribed.

Do not bandage, cover or wrap the treatment area unless directed by the physician. Avoid use of clotrimazole and betamethasone dipropionate cream in the diaper area, as diapers or plastic pants may constitute occlusive dressing. Report any signs of local adverse reactions to the physician.

Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use. This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved. Notify the physician if there is no improvement after 1 week of treatment for tinea cruris or tinea corporis, or after 2 weeks for tinea pedis.

Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA I600-5511/14A GW7100 Revised – July 2016

Glossary — plain-language definitions of medical terms used in this label:

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adrenal insufficiency: A condition where the adrenal glands do not make enough of certain needed hormones, such as cortisol, a stress hormone.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

contact dermatitis: A skin rash caused by touching something that irritates the skin or triggers an allergy.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

edema: Swelling caused by extra fluid trapped in the body's tissues.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

fertility: The natural ability to become pregnant or to father a child.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

intramuscular: An injection given deep into a muscle; often written as IM.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

pruritus: Itching of the skin.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

therapeutic equivalence: A rating meaning a generic can be expected to work the same and be as safe as the brand-name version.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 59088-0525-54 · PureTek 59088-0568-05 · PureTek →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

DermacinRx Zinc Oxide Skin Healing 200 mg/g Paste, 4 g

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📄 FDA label — Drug Facts FDA SPL

8 USE IN SPECIFIC POPULATIONS

12 CLINICAL PHARMACOLOGY

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