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SKIN A COOL Hydrocortisone Anti-Itch 10 mg/g Cream, 56.7 g — NDC 70288-0173-00 package photo

SKIN A COOL Hydrocortisone Anti-Itch 10 mg/g Cream, 56.7 g

by Ana-Cool, LLC · 56.7 g in 1 BOTTLE, PUMP (70288-173-00)
NDC 70288-0173-00
🏷️ FDA NDC (as labeled) 70288-173-00 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 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

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

🆔 Identity & classification

FDA NDC (as labeled) 70288-173-00
Product NDC 70288-173
11-digit billing NDC 70288017300
UNII WI4X0X7BPJ
Application # M017
SPL Set ID e3ea7406-e494-4038-9b28-8d0a28b4b834
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-03-01
Route TOPICAL
Dosage form CREAM
Substance HYDROCORTISONE
Why two NDCs? The FDA registers this code as 70288-173-00 — 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 → 70288-0173-00. 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

LabelerAna-Cool, LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code70288
First marketedMar 2021
Product typeHuman Otc Drug
Portfolio2 products on file
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

📗 Our plain-language guide HelloPharmacist
  • It's designed to calm down inflammation — so the redness, swelling, and itching that come with conditions like eczema should ease up, usually within a few days of consistent use. I...
  • What exactly is this cream supposed to do for my skin?
  • That's a really important question. Hydrocortisone is generally meant for short courses — typically a few weeks. Long-term or widespread use can cause side effects like skin thinni...
  • How long can I keep using it? Is it okay to use every day long-term?
📖 Read our full Hydrocortisone guide →
8
Nutrient depletion considerations

Hydrocortisone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Hydrocortisone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII UDA30A2JJY
    A plant extract from witch hazel used as an astringent and skin-conditioning agent in topical formulations. It helps tone and soothe the skin while functioning as a natural preservative.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII YRC528SWUY
    A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

17 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesAloe barbadensis (aloe vera gel) juice, aqua (deionized water), C12-15 alkyl benzoate, camellia sinensis (green tea) leaf extract, ceteareth-20, cetearyl alcohol, cetyl alcohol, ethylhexylglycerin, glycerin, glyceryl stearate, hamamelis virginiana (witch hazel) extract, helianthus annuus (sunflower) seed oil, PEG-100 stearate, petrolatum, phenoxyethanol, stearyl alcohol, tocopheryl acetate (vitamin E), zemea propanediol.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 systemPer gPer 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hydrocortisone 10 mg/g 00472-0321-26 Actavis 1 tube $0.112 AT Availability likely —
hydrocortisone 10 mg/g 00168-0015-16 E. 453.6 g $0.113 AT Availability likely —
Hydrocortisone 10 mg/g 00168-0020-16 E. 453.6 g $0.134 AT Availability likely —
Hydrocortisone 10 mg/g 62559-0430-01 ANI 1 tube $0.569 AT Availability likely —
Proctocort 10 mg/g 65649-0501-30 Salix 1 tube — AT Discontinued —
Dr. Sheffield Hydrocortisone Anti itch 10 mg/g 11527-0052-51 Sheffield 1 tube — — FDA listed —
CeraVe Developed with Dermatologists Anti Itch 10 mg/g 49967-0108-01 L'Oreal 1 tube — — FDA listed —
SKIN A COOL Hydrocortisone Anti-Itch 10 mg/gthis 70288-0173-00 Ana-Cool, 56.7 g — — FDA listed —
Ana Cool Rapid Soothing Cooling Formula 10 mg/g 70288-0714-01 Ana-Cool, 1 bottle — — FDA listed —
Thera plus Anti-itch with aloe Hydrocortisone 10 mg/g 80684-0038-01 Fourstar 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 73141-0622-28 A2A 1 tube — — FDA listed —
Thera Plus Maximum Strength Hydrocortisone 10 mg/g 80684-0145-00 Fourstar 42.5 g — — FDA listed —
Cortizone 10 Cooling Relief 10 mg/g 41167-0036-00 Chattem, 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 47682-0397-35 Unifirst 144 packets — — FDA listed —
Quadrydern 10 mg/g 59428-0403-57 Productos 1 tube — — FDA listed —
Viaderma Calm Anti-Itch 10 mg/g 71262-0014-15 ViaDerma 1 bottle — — FDA listed —
Hydrocortisone 10 mg/g 00924-1133-00 Acme 9 g — — FDA listed —
Alacort 10 mg/g 00316-0126-01 Crown 1 tube — AT FDA listed —
Hydrocortisone 10 mg/g 00316-0186-01 Crown 1 tube — AT FDA listed —
Winco Maximum Strength Hydrocortisone 10 mg/g 67091-0197-28 WINCO 1 tube — — FDA listed —
CVS Health Hydrocortisone Anti Itch 10 mg/g 69842-0155-10 CVS 24 packets — — Discontinued —
Aveeno 1% Hydrocortisone Anti-Itch Cream 10 mg/g 69968-0888-01 Kenvue 1 tube — — FDA listed —
Thera Plus Hydrocortisone Maximum Strength 10 mg/g 80684-0151-00 FOURSTAR 42.5 g — — FDA listed —
Quality Choice 10 mg/g 83324-0297-01 Chain 1 tube — — FDA listed —
Cortizone 10 10 mg/g 41167-0039-00 Chattem, 1 tube — — Discontinued —
Hydrocortisone 10 mg/g 51316-0227-00 CVS 1 tube — — FDA listed —
Crane Safety Hydrocortisone 10 mg/g 73408-0933-73 Crane 25 packets — — FDA listed —
Cortizone 10 Intensive Healing for Eczema 10 mg/g 41167-0331-00 Chattem, 1 tube — — FDA listed —
Family Wellness Max Strength 1 Hydrocortisone Cream 10 mg/g 55319-0982-00 Family 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 63629-1951-01 Bryant 1 tube — AT FDA listed —
Barmicil Plus 10 mg/g 69729-0103-11 OPMX 28 g — — FDA listed —
Hydrocortisone 10 mg/g 72162-1763-02 Bryant 1 tube — AT FDA listed —
THERAPLEX AIM Anti-Itch Moisturizing 10 mg/g 82280-0478-02 THERAPLEX, 56.7 g — — FDA listed —
Hydrocortisone 10 mg/g 82942-1003-01 J&A 9 g — — FDA listed —
Itch and Rash Cream 10 mg/g 84269-4506-01 Wildman 25 packets — — FDA listed —
Hydrocortisone 10 mg/g 85766-0166-10 Sportpharm 10 pouches — — FDA listed —
Hydrocortisone 10 mg/g 43473-0049-01 Nantong 9 g — — FDA listed —
SurviveX Hydrocortisone Cream 10 mg/g 43473-0313-01 Nantong 9 g — — FDA listed —
DermaCort Anti-itch 10 mg/g 54473-0117-28 Melaleuca, 28 g — — FDA listed —
Hydrocortisone 10 mg/g 00363-9981-02 Walgreens 1 tube — — FDA listed —
Cortizone 10 Intensive Healing 10 mg/g 41167-0035-00 Chattem, 1 tube — — FDA listed —
Thompson Hydrocortisone 1% 10 mg/g 73408-0937-73 Thompson 25 packets — — FDA listed —
Preparation H Soothing Relief Anti-Itch 10 mg/g 00573-0552-11 Haleon 1 tube — — FDA listed —
Equate Hydrocortisone 10 mg/g 79903-0092-01 WalMart 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 47682-0211-12 Unifirst 10 pouches — — FDA listed —
Hydrocortisone anti-itch plus 10 mg/g 49035-0732-02 Wal-Mart 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 51316-0230-00 CVS 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 72189-0209-28 DIRECT 28.4 g — AT FDA listed —
First Aid Only Hydrocortisone 1% Anti-Itch 10 mg/g 00924-5633-00 Acme 9 g — — FDA listed —
ProCure Hydrocortisone Cream Plus 10 mg/g 29784-0142-28 Rooftop 1 tube — — FDA listed —
Anti-itch 10 mg/g 53329-0091-01 Medline 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 61010-5800-02 Safetec 144 pouches — — FDA listed —
Aveeno Hydrocortisone ANTI-ITCH 10 mg/g 69968-0511-01 Kenvue 1 tube — — FDA listed —
Thera Plus Maximum Strength Hydrocortisone 10 mg/g 80684-0197-00 Fourstar 6 packets — — FDA listed —
Hydrocortisone 10 mg/g 84387-0005-01 ALLIED 28.4 g — — FDA listed —
WinCo Foods Hydrocortisone Cream Intensive Healing 10 mg/g 67091-0419-28 WINCO 1 tube — — FDA listed —
TheraCare Hydrocortisone Cream 10 mg/g 71101-0220-01 Veridian 1 tube — — FDA listed —
Preparation H Hydrocortisone 10 mg/g 00573-2830-10 Haleon 1 tube — — FDA listed —
Thera Plus Eczema Hydrocortisone Anti Itch 10 mg/g 80684-0146-00 Fourstar 28 g — — FDA listed —
FifthPulse Hydrocortisone 10 mg/g 87525-0003-01 WeCare 1 tube — — FDA listed —
Hydrocortisone 10 mg/g 47682-0933-73 Unifirst 25 pouches — — FDA listed —
Hydrocortisone 1% Anti-ItchCream 10 mg/g 00924-5634-00 Acme 9 g — — FDA listed —
Drs. Hydrocortisone Aloe Vera 10 mg/g 80489-0088-01 OL 1 tube — — FDA listed —
Quadriderm NF 10 mg/g 69729-0828-02 OPMX 1 tube — — FDA listed —
Diprospan 10 mg/g 69729-0794-02 OPMX 1 tube — — FDA listed —
Barmicil Plus 10 mg/g 69729-0830-01 OPMX 1 tube — — FDA listed —
Aerosoothe 10 mg/g 55305-0136-02 Aero 25 packets — — FDA listed —
Barmicil Plus 10 mg/g 69729-0834-01 OPMX 1 tube — — FDA listed —
Terramed Just Think Comfort Hydrocortisone 1% Cream 10 mg/g 83004-0051-01 Rida 1 jar — — 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

🏛️
2021
On the market since
Mar 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Hydrocortisone (matched by generic name) — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Hydrocortisone. CMS lists 11 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$19.92M
Claims incl. refills
699.9K
Beneficiaries
529.9K
Spend / beneficiary
$37.60
Spend / claim
$28.47
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for SKIN A COOL Hydrocortisone Anti-Itch (this brand).

Top reported reactions

Fatigue5,917
Condition Aggravated5,454
Nausea4,998
Rash4,907
Diarrhoea4,451
Headache4,425
Pain4,423

Age at onset

Neonate332
Infant314
Child1,040
Adolescent683
Adult7,947
Elderly3,424

Reporter sex

66,644 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization28,427
Life-threatening8,647
Disabling5,601
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70288-0173-00 You're viewing this 56.7 g in 1 BOTTLE, PUMP (70288-173-00) 2021-03-01 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
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
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.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 70288-173-00, 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: 70288-0173-00, written without dashes as 70288017300. 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 70288-0173-00, the first segment (70288) is the labeler code FDA assigned to Ana-Cool, LLC; the middle segment (0173) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 Ana-Cool, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Ana-Cool, LLC 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 ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 34 words ▾

Uses: Temporary relief of skin itching. The temporary relief of itching associated with minor skin irritations and rashes. Other uses of this product should be only under the advise and supervision of a doctor.

⏱️ Dosage and Administration 76 words ▾

Directions: Apply to affected area not more than 3 to 4 times daily. Adults and children 2 years of age and older: Do not use, consult a doctor. Children under 2 years of age: When practical, cleanse the affected area "(selected one or both of the following: with mild soap and warm water and rinse thoroughly". or "by patting or blotting with an appropriate cleansing pad").: Adults: consult a doctor. Children under 12 years of age:

⚠️ Warnings 127 words ▾

Warnings: For external use only. Do not use for for the treatment of diaper rash. Consult a doctor.

When using this product Avoid contact with the eyes. Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.

Do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocorstisone product unless you have consulted a doctor. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 6 words ▾

Active Ingredients: Hydrocortisone 1.0% Purpose Anti-itch

🧪 Inactive Ingredients 51 words ▾

Inactive ingredients: Aloe barbadensis (aloe vera gel) juice, aqua (deionized water), C12-15 alkyl benzoate, camellia sinensis (green tea) leaf extract, ceteareth-20, cetearyl alcohol, cetyl alcohol, ethylhexylglycerin, glycerin, glyceryl stearate, hamamelis virginiana (witch hazel) extract, helianthus annuus (sunflower) seed oil, PEG-100 stearate, petrolatum, phenoxyethanol, stearyl alcohol, tocopheryl acetate (vitamin E), zemea propanediol.

🎯 Purpose 2 words ▾

Purpose Anti-itch

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70277-0504-02 · Lonza 70288-0714-01 · Ana-Cool, →
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.