DERMACINRX ZINC OXIDE SKIN HEALING- zinc oxide paste

DermacinRx Zinc Oxide Skin Healing by

Drug Labeling and Warnings

DermacinRx Zinc Oxide Skin Healing by is a Otc medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - PureTek Corporation (785961046)