Label: EQUATE BABY ADVANCED HEALING- 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 May 23, 2017

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  • Active ingredient

    Petrolatum 41%

    Purpose

    Skin protectant

  • Uses

    • temporarily protects minor cuts, scrapes and 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 thoroughly with water

    Stop use and ask a doctor if

    condition worsens or does not improve within 7 days.

    Do not use on

    deep or puncture wounds, infections or lacerations

    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

  • Other information

    store at room temperature

  • Inactive ingredients

    Mineral Oil, Ceresin, Lanolin Alcohol, Panthenol, Glycerin, Bisabolol

  • Questions or comments?

    1-888-287-1915

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    EQUATE BABY ADVANCED HEALING 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.41 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-055-14397 g in 1 JAR; Type 0: Not a Combination Product05/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/22/2017
    Labeler - Wal-mart Stores Inc (051957769)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(49035-055)
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