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)

image description

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)

DermacinRx Zinc Oxide Skin Healing Paste(Zinc Oxide)