Label: BOA VIDA RECOVERY CREME - dimethicone cream 

  • NDC Code(s): 62654-142-01, 62654-142-04, 62654-142-05, 62654-142-11, view more
    62654-142-38
  • Packager: Central Solutions Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/13

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  • ACTIVE INGREDIENT

    Active Ingredients

    Dimethicone 1.5% (w/w)

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  • PURPOSE

    Purpose

    Skin protectant

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  • INDICATIONS & USAGE

    Uses

    Temporarily protects and helps relieve chapped or cracked skin

    Beneficial for face, hands, body and legs

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  • WARNINGS

    Warnings

    For External Use Only


    Do not use

    on deep or puncture wounds

    on animal bites

    on serious burns

    When using this product

    do not get into eyes

    Stop use and ask a doctor if

    condition worsens

    symptoms last for more than 7 days or clear up and occur within a few days

    Keep out of reach of children

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

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  • DOSAGE & ADMINISTRATION

    Directions

    Apply cream liberally as needed

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  • STORAGE AND HANDLING

    Other Information

    Protect from freezing.

    Avoid excessive heat

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified Water, Theobroma Grandiflorum Seed (Cupuacu Butter), Isopropyl Palmitate, Cetearyl Alcohol, Stearic Acid, Ceteareth 20, PEG-100 Stearate, Cyclopentasiloxane, Tocopherol (Vitamin E), Zea Mays Oil, Retinyl Palmitate (Vitamin A), Cholecalciferol (Vitamin D3), Oat Bran Extract, Glycerin, Allantoin, Caprylic/Capric Triglyceride, Glyceryl Dilaurate, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate, PEG-8, Aluminum Starch Octenylsuccinate, Isohexadecane, Isopropyl Isostearate, Triethanolamine, Carbomer, Fragrance

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  • PRINCIPAL DISPLAY PANEL

    BOA

    VIDA

    Recovery

    Creme

    to relieve and

    replenish dry,

    malnourished skin

    Formulated

    with Cupuacu Butter

    5 oz. (148 mL)

    container label

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  • INGREDIENTS AND APPEARANCE
    BOA VIDA RECOVERY CREME 
    dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:62654-142
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ISOPROPYL PALMITATE  
    CETOSTEARYL ALCOHOL  
    STEARIC ACID  
    POLYOXYL 20 CETOSTEARYL ETHER  
    PEG-100 STEARATE  
    CYCLOMETHICONE 5  
    TOCOPHEROL  
    CORN OIL  
    VITAMIN A PALMITATE  
    CHOLECALCIFEROL  
    OAT BRAN  
    GLYCERIN  
    ALLANTOIN  
    PHENOXYETHANOL  
    DMDM HYDANTOIN  
    IODOPROPYNYL BUTYLCARBAMATE  
    POLYETHYLENE GLYCOL 400  
    ALUMINUM STARCH OCTENYLSUCCINATE  
    ISOHEXADECANE  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62654-142-11 89 mL in 1 BOTTLE, PLASTIC
    2 NDC:62654-142-05 148 mL in 1 BOTTLE, PLASTIC
    3 NDC:62654-142-38 946 mL in 1 BOTTLE, PLASTIC
    4 NDC:62654-142-01 59 mL in 1 BOTTLE, PLASTIC
    5 NDC:62654-142-04 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 06/01/2011
    Labeler - Central Solutions Inc (007118524)
    Establishment
    Name Address ID/FEI Business Operations
    Central Solutions Inc 007118524 manufacture(62654-142)
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