Label: SAFEWAY- 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 December 15, 2011

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  • ACTIVE INGREDIENT

    PETROLATUM 41%

  • PURPOSE



    SKIN PROTECTANT
  • USES

    TEMPORARILY PROTECTS MINOR: CUTS, SCRAPES, BURNS.

    TEMPORARILY PROTECTS AND RELIEVES CHAPPED, CHAFED 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

    IRRITATION OR REDNESS DEVELOPS AND LASTS.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    APPLY AS NEEDED.

  • INACTIVE INGREDIENTS:

    MINERAL OIL, CERESIN, LANOLIN ALCOHOL, PANTHENOL, GLYCERIN, BISABOLOL.

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    SAFEWAY 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM41.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-330-14396 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/03/2012
    Labeler - SAFEWAY INC. (009137209)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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