Label: HEALTHY ACCENTS MOISTURE HEALING- 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 June 25, 2010

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  • ACTIVE INGREDIENT

    DIMETHICONE 1.0%

  • WARNING

    FOR EXTERNAL USE ONLY.

    When using this product

    AVOID CONTACT WITH EYES, IF CONTACT OCCURS, RINSE EYE THROUGHLY WITH WATER.

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS OR OCCUR AGAIN WITHIN A FEW DAYS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • Purpose

    Skin Protectant
  • Uses

    HELPS PREVENT AND TEMPORARILY PROTECTS CHAFED, CHAPPED OR CRACKED SKIN
  • Directions

    APPLY AS NEEDED.
  • Inactive Ingredients

    Water, White Petrolatum, Glycerin, Stearic Acid, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Glycine Soja (Soybean) Sterols, Lecithin, Tocopheryl Acetate, Retinyl Palmitate, Fragrance, Urea, Collagen Amino Acids, Sodium Stearoyl Lactylate, Sodium PCA, Potassium Lactate, Lactic Acid, Cetyl Alcohol, Glyceryl Stearate, Magnesium Aluminum Silicate, Carbomer, Stearamide AMP, Ethylene Brassylate, Triethanolamine, Corn Oil, Disodium EDTA, Methylparaben, DMDM Hydantoin, BHT, Titanium Dioxide

  • Package Front and Back Labels

    10 OZ Front and Back Labels: hac10.jpg10OZ Front and Back Labels

  • INGREDIENTS AND APPEARANCE
    HEALTHY ACCENTS  MOISTURE HEALING
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-315
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SOY STEROL (UNII: PL360EPO9J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    UREA (UNII: 8W8T17847W)  
    SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    POTASSIUM LACTATE (UNII: 87V1KMK4QV)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    CARBOMER 934 (UNII: Z135WT9208)  
    STEARAMIDOETHYL DIETHYLAMINE (UNII: 25FFJ4209Z)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CORN OIL (UNII: 8470G57WFM)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55316-315-10295 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/25/2010
    Labeler - DZA Brands LLC (090322194)
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