MY FAIR BABY DIAPER RASH- zinc oxide cream 
Delta Brands 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 Ingredient

Zinc Oxide 13%

Purpose

Skin Protection

Use

  • Helps treat and prevent diaper rash
  • Soothes and relieves irritated skin
  • Protects your baby's skin from wetness

Warnings

For external use only

When using this product

Avoid contact with the eyes

Stop use and ask a doctor if

Condition worsens or does not improve within 7 days or symptoms 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
  • Allow to dry
  • Ointment should be applied at every diaper change, specially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

Store at 20º to 25°C (68° to 77°F)

Inactive Ingredients

Water, Mineral Oil, Petrolatum, Cetyl Alcohol, Ceteareth-25, Glyceryl Monostearate, Beeswax, Microcrystaline Wax, Fragrance, Dimethicone, Aloe Barbadensis Leaf Extract (Aloe Vera), Tocopheryl Acetate, Methylparaben, Propylparaben, Methylchloroisothiazolinone, Methylisothiazolinone, Carbomer

Carton Label

Package Label

MY FAIR BABY  DIAPER RASH
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-321
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETEARETH-25 (UNII: 8FA93U5T67)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
WHITE WAX (UNII: 7G1J5DA97F)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20276-321-011 in 1 CARTON08/30/2011
1NDC:20276-321-1028 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:20276-321-021 in 1 CARTON08/30/2011
2NDC:20276-321-1543 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:20276-321-031 in 1 CARTON08/30/2011
3NDC:20276-321-2057 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:20276-321-041 in 1 CARTON08/30/2011
4NDC:20276-321-2570 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:20276-321-051 in 1 CARTON08/30/2011
5NDC:20276-321-3084 g in 1 TUBE; Type 0: Not a Combination Product
6NDC:20276-321-061 in 1 CARTON02/01/2019
6NDC:20276-321-45127 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01608/30/2011
Labeler - Delta Brands Inc (102672008)

Revised: 9/2023
Document Id: 04cad5ea-ec50-d17a-e063-6294a90a68f5
Set id: 90756439-3ec0-4c89-90a1-28318810c3b7
Version: 4
Effective Time: 20230907
 
Delta Brands Inc