Label: VASELINE INTENSIVE RESCUE CLINICAL THERAPY FRAGRANCE FREE- dimethicone lotion

  • 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 November 15, 2012

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  • ACTIVE INGREDIENT

    Active ingredient

    Dimethicone (1%)

  • PURPOSE

    Purpose

    skin protectant

  • INDICATIONS & USAGE

    Uses

    ● temporarily protects and helps relieve chapped or cracked skin● helps protect from the drying effects of wind and cold weather

  • WARNINGS

    Warnings

    For External Use Only

    When using this product do not get into eyes.

    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 on   ● deep or puncture wounds  ● animal bites  ● serious burns

    Keep out of reach of children.  If swallowed get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    apply as needed

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Glycerin, Isopropyl Palmitate, Distearyldimonium Chloride, Cetyl Alcohol, Mineral Oil, Steareth-21, Borago Officinalis Seed Oil, Glycine Soja (Soybean) Sterol, Petrolatum, Tocopheryl Acetate, Stearic Acid, Lecithin, Tapioca Starch, Stearyl Stearate, Sodium Chloride, Linoleic Acid, Linolenic Acid, Ethylene Brassylate, Methylparaben, Propylparaben, DMDM Hydantoin, Titanium Dioxide.

  • QUESTIONS

    QUESTIONS & COMMENTS? Call 1-800-457-7084

  • PDP 6.8 fl. oz.

    Vaseline Intensive Care Clinical Fragrance Free

  • 6.8 fl. oz. carton

    Vaseline Intensive Care Clinical Fragrance Free Carton

  • INGREDIENTS AND APPEARANCE
    VASELINE  INTENSIVE RESCUE CLINICAL THERAPY FRAGRANCE FREE
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1038
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARETH-21 (UNII: 53J3F32P58)  
    BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    STEARYL STEARATE (UNII: 5WX2EGD0DK)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1038-21 in 1 CARTON
    1NDC:64942-1038-1200 mL in 1 BOTTLE, PLASTIC
    2NDC:64942-1038-350 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/23/2008
    Labeler - Conopco Inc. d/b/a Unilever (001375088)
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