A AND A DIAPER RASH CREAM  - dimethicone and zinc oxide cream 
BioZone Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredientsPurpose
Dimethicone 1%Diaper rash Cream
Zinc Oxide 10%Diaper rash Cream

Uses

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

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

A+A Diaper Rash Cream

A AND A DIAPER RASH CREAM  
dimethicone and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55379-407
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55379-407-04113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34706/15/2013
Labeler - BioZone Laboratories, Inc. (555564293)
Establishment
NameAddressID/FEIBusiness Operations
BioZone Laboratories, Inc.555564293manufacture(55379-407)

Revised: 7/2013
Document Id: f050e1de-72f4-41b2-b8c7-c6e3caf441da
Set id: 45a42b10-e42a-4e98-95b8-777f995c5e09
Version: 1
Effective Time: 20130714
 
BioZone Laboratories, Inc.