BABY LOVE PERSONAL CARE DIAPER RASH (ZINC OXIDE) CREAM [DELTA BRANDS & PRODUCTS LLC]

BABY LOVE PERSONAL CARE DIAPER RASH (ZINC OXIDE) CREAM [DELTA BRANDS & PRODUCTS LLC]
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NDC 72133-321-45
Set ID 69c1db68-508a-e6e1-e053-2a91aa0a8568
Category HUMAN OTC DRUG LABEL
Packager Delta Brands & Products LLC
Generic Name
Product Class
Product Number
Application Number PART347
  • Active Ingredient

    Zinc oxide 13%

  • Purpose

    Skin Protectant

  • Uses

    ■ helps treat and prevent diaper rash

    ■ soothes and relieves irritated skin

    ■ protects your baby's skin from wetness

  • Warnings

    For external use only

  • When using this product

    ■ avoid contact with eyes

  • Stop use and ask a doctor if

    ■ condition worsens or does not improve within 7 days or symptoms clear up and occur again in 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 ■ allow to dry ■ ointment should be applied at every diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

  • Other Information

    ■ store at 20º to 25ºC (68º to 77ºF)

  • Inactive Ingredients

    water, mineral oil, petrolatum, yellow wax, dimethicone, sorbitan sesquioleate, microcrystalline wax, PEG-30 dipolyhydroxysterate, phenoxyethanol, potassium hydroxide, alpha-tocopherol acetate, aloe vera extract

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    BABY LOVE PERSONAL CARE  DIAPER RASH
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72133-321
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72133-321-45127 g in 1 TUBE; Type 0: Not a Combination Product04/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/09/2018
    Labeler - Delta Brands & Products LLC (080999173)

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