DG BABY DIAPER RASH- zinc oxide ointment 
DOLGENCORP 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 40%

PURPOSE

SKIN PROTECTANT

USES

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

  • CONDITION WORSENS
  • SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS

DO NOT USE ON

  • DEEP PUNCTURE WOUNDS
  • ANIMAL BITES
  • SERIOUS BURNS

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

DIRECTIONS

OTHER INFORMATION

STORE BETWEEN 20°-25°C (68°-77°F)

INACTIVE INGREDIENTS

BHA, COD LIVER OIL, ETHYLHEXYLGLYCERIN, FRAGRANCE (PARFUM), LANOLIN, MINERAL OIL, PETROLATUM, PHENOXYETHANOL, TALC, WATER (AQUA)

QUESTIONS OR COMMENTS?

1-888-309-9030

LABEL COPY

IMAGE OF THE LABEL

DG BABY DIAPER RASH 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-334
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
COD LIVER OIL (UNII: BBL281NWFG)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LANOLIN OIL (UNII: OVV5IIJ58F)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TALC (UNII: 7SEV7J4R1U)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-334-04113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2015
Labeler - DOLGENCORP INC (068331990)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(55910-334)

Revised: 7/2015
Document Id: dbb6ba09-532d-4f11-9809-b7b425fbac45
Set id: 5a8a9fda-6b60-4087-81a2-45e1ef5d1b1e
Version: 1
Effective Time: 20150702
 
DOLGENCORP INC