Label: VITAMINS A AND D DIAPER RASH- lanolin and petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 4, 2011

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  • ACTIVE INGREDIENT

    LANOLIN 15.5 PERCENT

    PETROLATUM 53.4 PERCENT

  • PURPOSE

    SKIN PROTECTANT

    SKIN PROTECTANT

  • USES

    HELPS TREAT AND PREVENT DIAPER RASH.

    TEMPORARILY PROTECTS MINOR: CUTS SCRAPES BURNS.

    TEMPORARILY PROTECTS AND RELIEVES CHAPPED, CHAFE OR CRACKED SKIN AND LIPS.

    HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

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


    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    CONDITION WORSENS

    SYMPTOMS LAST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS


    DO NOT USE ON

    DEEP OR 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

    FOR SKIN PROTECTANT USE APPLY AS NEEDED

    FOR DIAPER RASH USE

        CHANGE WET AND SOILED DIAPERS PROMPTLY

         CLEAN THE DIAPER AREA, AND ALLOW TO DRY

         APPLY OINTMENT AS OFTEN AS REQUIRED, WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE 

         PROLONGED.

  • INACTIVE INGREDIENTS

    COD LIVER OIL, FRAGRANCE, LIGHT MINERAL OIL, MICROCRYSTALLINE WAX, PARAFFIN.

  • QUESTIONS OR COMMENTS

    1-866-695-3030

  • OTHER INFORMATION

    STORE BETWEEN 20 DEGREES CELSIUS TO 25 DEGREES CELSIUS (68 DEGREES FAHRENHEIT TO 77 DEGREES FAHRENHEIT).

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF RA1

  • INGREDIENTS AND APPEARANCE
    VITAMINS A AND D DIAPER RASH  
    lanolin and petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN15.5 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM53.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-3401-6454 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/04/2011
    Labeler - RITE AID (014578892)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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