Label: DG BABY DIAPER RASH- zinc oxide ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated July 2, 2015

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  • ACTIVE INGREDIENT

    ZINC OXIDE 40%

    PURPOSE

    SKIN PROTECTANT

  • USES

    • HELPS TREAT AND PREVENT DIAPER RASH
    • PROTECTS CHAFED SKIN DUE TO DIAPER RASH
    • HELPS SEAL OUT WETNESS
  • 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

    • CHANGE WET AND SOILED DIAPERS PROMPTLY
    • CLEAN THE DIAPER AREA AND ALLOW TO DRY
    • APPLY OINTMENT LIBERALLY AS OFTEN AS REQUIRED WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGED.
  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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