Drug Facts

Active ingredients

Zinc Oxide 5.0%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash
Protects chafed skin associated with diaper rash and helps protect from wetness

Warnings

When using this product avoid contact with eyes. For external use only.

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 children

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

Directions

Change wet and soiled diapers promptly. Cleanse the affected area, and allow to dry. Apply cream liberally as often as necessary, with each change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive ingredients

BeesWax, Butyrospermum parkii (shea) butter, Carbopol, Cetylstearyl alcohol, Cholecalciferol (Vitamin D), Citric Acid, Ciclopentasiloxane, cyclotetrasiloxane, Dimethicone, Disodium EDTA, DMDM Hydantoin, Ethylhexyl palmitate, Glycerin, Glycina Soja (soybean)oil, Isopropyl palmitate, PEG-40 Castor Oil, Purified Water, Retinyl palmitate (Vitamin A), Sodium Hydroxide, Tocopherol(Vitamin E).

Akin Diaper Rash Cream 170 g

Tube label

AKIN DIAPER RASH
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69822-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
WATER (UNII: 059QF0KO0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69822-003-06	170 g in 1 TUBE; Type 0: Not a Combination Product	04/25/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	04/25/2019

Labeler - Southern Sales & Service, Inc. (013114906)

Registrant - Southern Sales & Service, Inc. (013114906)