INFANT DIAPER CREAM ANNE GEDDES- zinc oxide cream 
HR Pharma LLC

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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Infant Diaper Cream

Active inredient (in each dose)          Purpose

Zinc Oxide 10% .................................. Skin Protectant

  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness

Keep out of reach of children

If Swallowed get medical help or contact a Poison Control Center immediately

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms last mor than 7 days or clear up and occur again within a few days

For external use only when using this product. Do no get into eyes

Directions:

  • Change wet and soiled diapers promptly
  • Cleanse the 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
  • Suitable for infants under 1 and children up to 3 year old

Water, Mineral oil, Petrolatum, Glycerin, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Beeswax, Hydrogenated Castor Oil, Stearoxy Dimethicone, Dimethicone, Isostearyl Lactate, Polyglyceryl-4 Isostearate, Magnesium Sulfate, Panthenol, Sodium Chloride, Phenoxyethanol, Caprylyl Glycol, Tocopheryl Acetate, Allantoin, Helianthus Annuus (Sunflower) Seed Oil, Pantolactone, Chamomilla Recutita (Matricaria) Flower Oil

Infant Diaper Cream

3.4 fl oz (100 g)


Drug Facts

label

INFANT DIAPER CREAM  ANNE GEDDES
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69976-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOSTEARYL LACTATE (UNII: 8OM3O3YPML)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALLANTOIN (UNII: 344S277G0Z)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
PANTOLACTONE, (+/-)- (UNII: IID733HD2M)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69976-001-01100 g in 1 TUBE; Type 0: Not a Combination Product07/10/201511/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/10/201511/18/2016
Labeler - HR Pharma LLC (079850639)
Registrant - Fleet Laboratories LTD (217269489)
Establishment
NameAddressID/FEIBusiness Operations
Fleet Laboratories LTD217269489manufacture(69976-001)

Revised: 7/2018
 
HR Pharma LLC