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NDC 59088-0563-01 DermacinRx Zinc Oxide Skin Healing 200 mg/g Details

DermacinRx Zinc Oxide Skin Healing 200 mg/g

DermacinRx Zinc Oxide Skin Healing is a TOPICAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by PureTek Corporation. The primary component is ZINC OXIDE.

Product Information

NDC	59088-0563
Product ID	59088-563_be0a852e-f302-4990-a4ac-f6dbd9474285
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DermacinRx Zinc Oxide Skin Healing
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	TOPICAL
Active Ingredient Strength	200
Active Ingredient Units	mg/g
Substance Name	ZINC OXIDE
Labeler Name	PureTek Corporation
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59088-0563-01 (59088056301)

Pricing Information	N/A
NDC Package Code	59088-563-01
Billing NDC	59088056301
Package	4 g in 1 PACKET (59088-563-01)
Marketing Start Date	2016-08-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 541b8da8-f0c1-4f57-94a7-193084d9a611 Details

Active ingredient

Zinc Oxide 20.0%

(3.0% as Calamine)

Purpose

Skin Protectant

Uses

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

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.

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

Other information

protect from freezing
avoid excessive heat

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.

DermacinRx Zinc Oxide Skin Healing Paste (4 g packet)

INGREDIENTS AND APPEARANCE

DERMACINRX ZINC OXIDE SKIN HEALING

zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59088-563
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
KUKUI NUT OIL (UNII: TP11QR7B8R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
SAFFLOWER OIL (UNII: 65UEH262IS)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
NIACINAMIDE (UNII: 25X51I8RD4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GINGER OIL (UNII: SAS9Z1SVUK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59088-563-01	4 g in 1 PACKET; Type 0: Not a Combination Product	08/03/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/03/2016

Labeler - PureTek Corporation (785961046)

Revised: 2/2019

Document Id: be0a852e-f302-4990-a4ac-f6dbd9474285

Set id: 541b8da8-f0c1-4f57-94a7-193084d9a611

Version: 2

Effective Time: 20190206