Label: BAMBOOBIES DIAPER RASH- zinc oxide 15% spray

  • NDC Code(s): 72839-132-03
  • Packager: Derma Care Research Labs, LLC
  • 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 August 29, 2023

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  • ACTIVE INGREDIENT

    Zinc Oxide 15%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Helps treat and prevent diaper rash, protects chafed skin due to diaper rash.

  • WARNINGS

    For external use only.

    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

    Change wet and soiled diapers promptly. Cleanse the diaper area. Allow to dry. Shake well before each use. Spray liberally onto affected area with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged. Apply as needed.

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Bentonite, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis flower Extract, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, chamomilla Recutita (Matricaria) Flower Extract, Coco-Glucoside, Glycerin, Glyceryl Oleate, Glyceryl Rosinate, Helianthus Annuus (Sunflower) Seed Oil, Microcrystalline Cellulose, Olea Europaea (Olive) Fruit Oil, Olea Europaes 9Olive) Oil Unsaponifiables, Propanediol, Ricinus Communis (Castor) Seed Oil, Water.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    BAMBOOBIES DIAPER RASH 
    zinc oxide 15% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-132
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERYL ROSINATE (UNII: SD112V492J)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-132-03100.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/09/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01603/09/2023
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(72839-132)
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