Label: BUYBUYBABY QUICK RELIEF DIAPER RASH CREAM- zinc oxide cream

  • NDC Code(s): 63940-113-16, 63940-113-17
  • Packager: Harmon Stores 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 November 4, 2021

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  • ACTIVE INGREDIENT

    Active ingredient

    Zinc Oxide, 13.0%

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses

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

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison

    Control Center right away

  • DOSAGE & ADMINISTRATION

    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 at any time when exposure to wet diapers may

    be prolonged

  • STORAGE AND HANDLING

    Other information

    -store at 20 to 25 C    (68 to 77 F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe barbadensis leaf juice, beeswax, dimethicone,

    magnesium sulfate, methylparaben, microcrystalline wax,

    mineral oil, PEG-30 dipolyhydroxystearate, petrolatum,

    phenoxyethanol, polyglyceryl-3 diostearate,

    potassium hydroxide, proprylparaben, sorbitan,

    sesquioleate, tocopheryl acetate (vitamin E), water

  • DESCRIPTION

    Maximum Strength Diaper Rash Paste provides maximum strength relief

    overnight for baby's delicate skin. This rich and dermatologist-tested

    formula instantly forms a protection layer

    on your baby's skin to soothe and relieve discomfort caused

    by diaper rash.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BUYBUYBABY  QUICK RELIEF DIAPER RASH CREAM
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.69 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-113-171 in 1 CARTON12/07/2016
    1NDC:63940-113-16113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/07/2016
    Labeler - Harmon Stores Inc. (804085293)
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