Label: HARMON FACE VALUES ADVANCED SEVERE DRY SKIN 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 December 12, 2018

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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 50 gram Tube




  • PRINCIPAL DISPLAY PANEL

    Image of 10 gram tube

  • PRINCIPAL DISPLAY PANEL

    Image of 10g tube carton

  • INGREDIENTS AND APPEARANCE
    HARMON FACE VALUES ADVANCED   SEVERE DRY SKIN THERAPY
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66353-100
    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:66353-100-102 in 1 CARTON11/21/2011
    110 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:66353-100-0150 g in 1 TUBE; Type 0: Not a Combination Product11/21/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/21/2011
    Labeler - Delta Pharma Inc. (200161730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delta Pharma Inc.200161730manufacture(66353-100)
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