Label: BABY LOVE PERSONAL CARE DIAPER RASH- zinc oxide cream

  • NDC Code(s): 72133-321-45
  • Packager: Delta Brands & Products LLC
  • Category: HUMAN OTC DRUG LABEL

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 April 13, 2018

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  • 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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