Label: BOA VIDA CANOPY  - dimethicone cream 

  • Label RSS
  • NDC Code(s): 62654-144-04, 62654-144-05
  • 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 2.0% (w/w)

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  • PURPOSE

    Purpose

    Skin protectant

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  • INDICATIONS & USAGE

    Uses

    Helps treat and prevent diaper rash

    Protects minor skin irritation due to diaper rash and helps seal out wetness

    Temporarily protects and helps relieve chapped or cracked skin

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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 again 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 liberally as often 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

    Water, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate,Cyclotetrasiloxane, Cyclopentasiloxane, Mineral Oil, Isopropyl Palmitate, Ethylhexyl Palmitate, Theobroma Grandiflorum Seed (Cupuacu Butter), Glycerin, Cetyl Dimethicone, Tocopherol (Vitamin E), Beeswax, Diazolidinyl Urea, Hydrogenated Castor Oil, Retinyl Palmitate (Vitamin A), Cholecalciferol (Vitamin D3), Beeswax, Zea Mays Oil, Methyl Paraben, Fragrance, Sodium Chloride



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  • PRINCIPAL DISPLAY PANEL

    BOA

    VIDA

    Canopy

    skin protectant

    helps prevent minor

    skin irritation

    Formulated

    with

    Cupuacu Butter

    5 fl oz. (148 mL)

    container label

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  • INGREDIENTS AND APPEARANCE
    BOA VIDA CANOPY  
    dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:62654-144
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    POLYGLYCERYL-4 ISOSTEARATE  
    HEXYL LAURATE  
    QUADROSILAN  
    CYCLOMETHICONE 5  
    MINERAL OIL  
    ISOPROPYL PALMITATE  
    ETHYLHEXYL PALMITATE  
    THEOBROMA GRANDIFLORUM SEED  
    GLYCERIN  
    TOCOPHEROL  
    YELLOW WAX  
    DIAZOLIDINYL UREA  
    HYDROGENATED CASTOR OIL  
    VITAMIN A PALMITATE  
    CHOLECALCIFEROL  
    CORN OIL  
    METHYLPARABEN  
    SODIUM CHLORIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62654-144-05 148 mL in 1 BOTTLE, PLASTIC
    2 NDC:62654-144-04 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 11/01/2011
    Labeler - Central Solutions Inc (007118524)
    Establishment
    Name Address ID/FEI Business Operations
    Central Solutions Inc 007118524 manufacture(62654-144)
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