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

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 January 28, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Dimethicone 1.5% (w/w)

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses

    Temporarily protects and helps relieve chapped or cracked skin

    Beneficial for face, hands, body and legs

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply cream liberally as needed

  • STORAGE AND HANDLING

    Other Information

    Protect from freezing.

    Avoid excessive heat

  • 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

  • PRINCIPAL DISPLAY PANEL

    BOA

    VIDA

    Recovery

    Creme

    to relieve and

    replenish dry,

    malnourished skin

    Formulated

    with Cupuacu Butter

    5 oz. (148 mL)

    container label

  • INGREDIENTS AND APPEARANCE
    BOA VIDA RECOVERY CREME 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-142
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CORN OIL (UNII: 8470G57WFM)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    OAT BRAN (UNII: KQX236OK4U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62654-142-1189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2011
    2NDC:62654-142-05148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2011
    3NDC:62654-142-38946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2011
    4NDC:62654-142-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2011
    5NDC:62654-142-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2011
    Labeler - Central Solutions Inc (007118524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions Inc007118524manufacture(62654-142)
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