Label: BOA VIDA CALVIDA- zinc oxide cream

  • NDC Code(s): 62654-145-04, 62654-145-05
  • 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

    Zinc Oxide 20% (w/w)

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses

    Helps treat and prevent diaper rash

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

  • 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 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.

  • DOSAGE & ADMINISTRATION

    Directions

    For Diaper Rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.

    Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

    For Skin Protection: Apply liberally as needed.

  • STORAGE AND HANDLING

    Other Information

    Protect from freezing.

    Avoid excessive heat

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified Water, Polyglyceryl-4 Isostearate and Cetyl PEG/PPG-10/1 Dimethicone and Hexyl Laurate, Mineral Oil, Isopropyl Palmitate, Ethylhexyl Palmitate, Theobroma Grandiflorum Seed (Cupuacu Butter), Calamine, Glycerin, Cetyl Dimethicone, Dimethicone, SD Alcohol 40-B, Sodium Chloride, Diazolidinyl Urea, Menthol, Hydrogenated Castor Oil, Beeswax, Tocopherol (Vitamin E), Methyl Paraben, Zea Mays Oil and Retinyl Palmitate (Vitamin A) and Cholecalciferol (Vitamin D3)

  • PRINCIPAL DISPLAY PANEL

    BOA

    VIDA

    Calvida

    protectant shield

    helps treat minor

    skin irritation

    Formulated

    with

    Cupuacu Butter

    5 fl oz. (148 mL)

    container label

  • INGREDIENTS AND APPEARANCE
    BOA VIDA CALVIDA 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-145
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    THEOBROMA GRANDIFLORUM SEED (UNII: Q7RNT1G37V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    MENTHOL (UNII: L7T10EIP3A)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CORN OIL (UNII: 8470G57WFM)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62654-145-05148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2011
    2NDC:62654-145-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/01/2011
    Labeler - Central Solutions Inc (007118524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions Inc007118524manufacture(62654-145)
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