My Fair Baby Diaper Rash

Dosage form: cream
Ingredients: ZINC OXIDE 13g in 100g
Labeler: Delta Brands Inc
NDC Code: 20276-321

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.

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

WarningsFor external use only

When using this productAvoid contact with 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 20 to 25C (68 to 77F)

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 LabelPackage Label


MY FAIR BABY  DIAPER RASH
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-321
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC CATION) ZINC OXIDE13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
MINERAL OIL 
PETROLATUM 
CETYL ALCOHOL 
CETEARETH-25 
GLYCERYL MONOSTEARATE 
WHITE WAX 
MICROCRYSTALLINE WAX 
DIMETHICONE 
ALOE VERA LEAF 
METHYLPARABEN 
PROPYLPARABEN 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage Description
1NDC:20276-321-011 TUBE (TUBE) in 1 CARTON
1NDC:20276-321-1028 g in 1 TUBE
2NDC:20276-321-021 TUBE (TUBE) in 1 CARTON
2NDC:20276-321-1543 g in 1 TUBE
3NDC:20276-321-031 TUBE (TUBE) in 1 CARTON
3NDC:20276-321-2057 g in 1 TUBE
4NDC:20276-321-041 TUBE (TUBE) in 1 CARTON
4NDC:20276-321-2570 g in 1 TUBE
5NDC:20276-321-051 TUBE (TUBE) in 1 CARTON
5NDC:20276-321-3084 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/30/2011
Labeler - Delta Brands Inc (102672008)
Establishment
NameAddressID/FEIOperations
Ningbo Pulisi Daily Chemical Co. Ltd.529047265manufacture

Revised: 08/2011
 
Delta Brands Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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