Label: BUDDLE BOTTOM BUDDY DIAPER CREAM- zinc oxide cream

  • NDC Code(s): 83178-102-04
  • Packager: The Goodsprout Company LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

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  • Active Ingredient

    Zinc Oxide 20%

  • Purpose

    Zinc oxide 20%...................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 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.

  • Directions

    • change wet and soiled diapers promptly
    • cleanse the diaper area, and 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.
  • Other Information

    • store at 20°C to 25°C (68°F to77°F)
    • may stain clothing
  • Inactive Ingredients

    white petrolatum, water, anhydrous lanolin, zea mays (corn) starch, tridecyl trimellitate, glycerin, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-3 diisostearate, beeswax white, ceramide AP, ceramide NP, ceramide EOP, honey, alpha-glucan oligosaccharide, lactobacillus ferment, subtilisin, inulin, phytosphingosine, cetyI alcohol, lactic acid, xanthan gum, ethylhexylglycerin, benzyl alcohol, caprylyl glycol, carbomer, dehydroacetic acid, sodium chloride, sodium lauroyl lactylate, cholesterol

  • Questions?

    Call 833-777-6880

  • PRINCIPAL DISPLAY PANEL

    Bottom Buddy

    buddle

    Diaper Cream

    Prevent diaper rash

    Nourish baby's skin and normalize pH

    ZINC OXIDE SKIN PROTECTANT

    PROTECT

    NET WT 4 OZ (113 g)

    buddle Bottom Buddy Diaper Cream

  • INGREDIENTS AND APPEARANCE
    BUDDLE BOTTOM BUDDY DIAPER CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83178-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    SUBTILISIN (UNII: 0ZP13EBC5Y)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    WATER (UNII: 059QF0KO0R)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LANOLIN (UNII: 7EV65EAW6H)  
    INULIN (UNII: JOS53KRJ01)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CERAMIDE NP (UNII: 4370DF050B)  
    HONEY (UNII: Y9H1V576FH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83178-102-04113 g in 1 TUBE; Type 0: Not a Combination Product12/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/07/2023
    Labeler - The Goodsprout Company LLC (118309464)
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