Label: REXALL PETROLEUM WITH VITAMIN E AND ALOE- petrolatum jelly

  • 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 March 4, 2015

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  • ACTIVE INGREDIENT

    PETROLATUM 99.8%

    PURPOSE

    SKIN PROTECTANT

  • USE

    • TEMPORARILY PROTECTS MINOR:
    • CUTS
    • SCRAPES
    • BURNS
    • TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED 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

    DO NOT GET INTO EYES

    STOP USE AND ASK A DOCTOR IF

    CONDITIONS LASTS MORE THAN 7 DAYS

    DO NOT USE ON

    • DEEP PUNCTURE WOUNDS
    • ANIMAL BITES
    • SERIOUS BURNS

    KEEP OUT OF REACH OF CHIDREN

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

  • DIRECTIONS

    APPLY AS NEEDED

  • INACTIVE INGREDIENTS

    ALOE BARBADENSIS LEAF JUICE, FRAGRANCE (PARFUM), TOCOPHERYL ACETATE

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    REXALL  PETROLEUM WITH VITAMIN E AND ALOE
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-316
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-316-13368 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/03/2015
    Labeler - DOLGENCORP INC (068331990)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(55910-316)
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