A AND A DIAPER RASH CREAM- dimethicone and zinc oxide cream

A AND A Diaper Rash cream by

Drug Labeling and Warnings

A AND A Diaper Rash cream by is a Otc medication manufactured, distributed, or labeled by BioZone Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Dimethicone 1%	Diaper rash Cream
Zinc Oxide 10%	Diaper rash Cream

Uses

• helps treat and prevent diaper rash
• protects minor skin irritation due to diaper rash and helps seal out wetness

Warnings

For external use only

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

Directions

• change wet and soiled diapers promptly
• cleanse the diaper area, and allow to dry
• apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

store between 20°C to 25 °C ( 68° to 77°F)

Inactive Ingredients

Aloe barbadensis extract, benzyl alcohol, coconut oil, cod liver oil ( contains vitamin A & Vitamin D), fragrance, glyceryl oleate, light mineral oil, ozokerite, paraffin, propylene glycol, sorbitol, synthetic beeswax, water

Principal Display Panel

A+A Diaper Rash Cream

with DIMETHICONE AND ZINC OXIDE

Helps treat and calm diaper rash

Allows Skin to heal naturally

A+A Diaper Rash Cream

INGREDIENTS AND APPEARANCE

A AND A DIAPER RASH CREAM  
dimethicone and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55379-407
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SAFFLOWER OIL (UNII: 65UEH262IS)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55379-407-04	113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	06/15/2013

Labeler - BioZone Laboratories, Inc. (555564293)

Establishment
Name	Address	ID/FEI	Business Operations
BioZone Laboratories, Inc.		555564293	manufacture(55379-407)