Label: BOTAO BABY DIAPER RASH CREAM- zinc oxide cream

  • NDC Code(s): 69435-1501-1, 69435-1501-2
  • Packager: Peer Pharm Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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  • Drug Facts

  • Active Ingredients(in each 30 ml)

    Zinc Oxide 12%

    Purpose

    Sunscreen

  • Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin due to diaper rash and helps seal out wetness
  • warnings

    • For external use only.

    Do not use

    • on damaged or broken skin.

    When using this product,

    • Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    • if rash or irritation develops and lasts.

    Keep out of reach of children.

    If swallowed, call a poison control center or get medical help right  away.

  • Directions

    Change Wet and Soiled Diapers Promptly

    Cleanse the diaper area

    Allow to dry

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

  • Inactive Ingredients

    Coconut Alkanes, Cocos Nucifera (Virgin Coconut) Oil, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Ricinus Communis (Castor) Seed Oil*, Ethyl Macadamiate, Shea Butter Ethyl Ester, Glycerin*, Polyglyceryl Esters, Polyhydroxystearic Acid, Citrus Aurantium Dulcis (Orange) Peel Wax, Simmondsia Chinensis (Jojoba) Seed Oil*, Jojoba Esters, Coco-Caprylate/Caprate, Copernicia Cerifera (Carnauba) Wax*, Butyrospermum Parkii (Shea Butter) Fruit*, Tocopherol (Vitamin E), Capric Acid, Silica, Disteardimonium Hectorite, Kaolin, Argania Spinosa (Argan) Kernel Oil, Rosa Canina Seed (Rosehip) Oil, Lavandula Angustifolia (Lavender) Oil, Olea Europaea (Olive) Oil, Origanum Vulgare (Oregano) Leaf Extract,
    Tocopheryl Acetate, Basabolol, Malic Acid. May Contain: Iron Oxides.
    *Certified Organic

  • Other Information

    • Store in room temparture
    • protect from freezing
    • may stain clothing
  • Package Labeling

    TUBEBOX

  • INGREDIENTS AND APPEARANCE
    BOTAO BABY DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9 g  in 71 g
    Inactive Ingredients
    Ingredient NameStrength
    HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    ALOE (UNII: V5VD430YW9)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL 1-PHOSPHATE (UNII: 48G71659RB)  
    CHAMOMILE (UNII: FGL3685T2X)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69435-1501-21 in 1 BOX05/19/2022
    1NDC:69435-1501-170.8 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/19/2022
    Labeler - Peer Pharm Ltd. (514678390)
    Registrant - Peer Pharm Ltd. (514678390)
    Establishment
    NameAddressID/FEIBusiness Operations
    Peer Pharm Ltd.514678390manufacture(69435-1501)
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