Label: BEBE BOTTOMS- zinc oxide spray

  • NDC Code(s): 51672-5318-3, 51672-5318-7
  • Packager: TARO PHARMACEUTICALS U.S.A., INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc oxide 10%

  • Purpose

    Skin protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only

    When using this product

    • do not get into eyes

    Stop use and contact a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and reoccur within a few days
    • not to be applied over deep or puncture wounds, infection or lacerations

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
  • Directions

    • shake well before use
    • 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.
  • Other information

    Store at room temperature, below 77°F.

  • Inactive ingredients

    alkyl-alcohols, alkyl glucoside, calendula officinalis flower extract, caprylyl glycol, caprylhydroxamic acid, chamomilla recutita (matricaria) flower extract, coco-caprylate/caprate, cocoglycerides, glycerin, oleic acid, potassium sorbate, propylene glycol, silica, sodium benzoate, water

  • Questions?

    call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by: Taro Pharmaceuticals U.S.A., Inc.,
    Hawthorne, NY 10532 PRODUCT OF NETHERLANDS

  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

    bébé
    BOTTOMS™

    DIAPER RASH
    CRÈME SPRAY

    10% ZINC OXIDE
    SKIN PROTECTANT

    PREVENTS & TREATS
    FOR DAILY USE

    NET WT. 3.4 OZ (100 mL)

    PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    BEBE BOTTOMS 
    zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-5318
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    caprylyl glycol (UNII: 00YIU5438U)  
    caprylhydroxamic acid (UNII: UPY805K99W)  
    CHAMOMILE (UNII: FGL3685T2X)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    glycerin (UNII: PDC6A3C0OX)  
    oleic acid (UNII: 2UMI9U37CP)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    propylene glycol (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    sodium benzoate (UNII: OJ245FE5EU)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-5318-31 in 1 CARTON12/01/2023
    150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:51672-5318-71 in 1 CARTON12/01/2023
    2100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01612/01/2023
    Labeler - TARO PHARMACEUTICALS U.S.A., INC. (145186370)
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