Label: HARMON FACE VALUES BABY HEALING ADVANCED THERAPY- 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 11, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient

    Petrolatum (41%)

  • PURPOSE

    Purpose

    Skin Protectant (ointment)

  • INDICATIONS & USAGE

    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

    Warning
    For external use only
  • WHEN USING

    When using this product, do not get into eyes

  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • DO NOT USE

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

    If swallowed, seek medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply as needed

  • INACTIVE INGREDIENT

    Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL

    Image of 85 gram Baby tube




  • INGREDIENTS AND APPEARANCE
    HARMON FACE VALUES BABY HEALING   ADVANCED THERAPY
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66353-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum41 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)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66353-200-2085 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/11/2012
    Labeler - Delta Pharma Inc. (200161730)
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