Label: IMAGE ESSENTIALS- white 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 May 6, 2015

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  • ACTIVE INGREDIENT

    WHITE PETROLATUM 100%

    PURPOSE

    SKIN PROTECTANT

  • USES

    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

    DO NOT USE ON

    • DEEP OR PUNCTURE WOUNDS
    • ANIMAL BITES
    • SERIOUS BURNS

    WHEN USING THIS PRODUCT

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

    STOP USE AND ASK A DOCTOR IF

    CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)

  • DIRECTIONS

    APPLY AS NEEDED

  • QUESTIONS OR COMMENTS?

    1-800-842-7886

  • INACTIVE INGREDIENT

    MINERAL OIL

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    IMAGE ESSENTIALS 
    white petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-350
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1000 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-350-14369 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34605/05/2015
    Labeler - KMART CORPORATION (008965873)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(49738-350)
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