AKIN DIAPER RASH- zinc oxide gel

Akin Diaper Rash by

Drug Labeling and Warnings

Akin Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Southern Sales & Service, Inc., GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredient                                               Purpose

Zinc Oxide   5%...............................................Skin Protectant

INACTIVE INGREDIENT

Purified Water, cyclotetrasiloxane , Isopropyl palmitate, Ethylhexyl palmitate, Glycerin, Cyclopentasiloxane, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Dimethicone, Tocopherol (Vitamin E), Zea Mays Oil, Retinyl palmitate(Vitamin A), Cholecalciferol (Vitamin D), Beeswax, Hydrogenated Castor Oil, Sodium Chloride, DMDM Hydantoin.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Helps treat and prevent diaper rash.

WARNINGS

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

DOSAGE & ADMINISTRATION

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.

PURPOSE

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

Akin Diaper Rash

INGREDIENTS AND APPEARANCE

AKIN DIAPER RASH 
zinc oxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69822-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
YELLOW WAX (UNII: 2ZA36H0S2V)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CORN OIL (UNII: 8470G57WFM)
DIMETHICONE (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MONOPHENYLHEPTAMETHYLCYCLOTETRASILOXANE (UNII: 50Q464790P)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69822-001-06	117 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/01/2019

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

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	manufacture(69822-001)