Label: BABY LOVE DIAPER RASH- zinc oxide cream

  • 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 July 25, 2020

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  • Drug Facts Active ingredients

    Zinc Oxide 13 %

  • Purpose

    Skin Protectant

  • Keep out of reach of children

    KEEP OUT OF REACH OF CHILDREN

  • 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 product

    • avoid contact with 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
  • Directions

    Gently clean diaper area and allow to dry. Apply ointment liberally with each diaper change and as often as desired.

  • Other information

    Store at 20° to 25°C (68° to 77°F)

  • Inactive ingredients


    Water, Mineral Oil, Petrolatum, Yellow Wax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline wax, Peg-30 Dipolyhydroxysterate, Magnesium Sulfate, Phenoxyethanol, Methylparaben, Potassium Hydroxide, Propylparaben, .Alpha.-Tocopherol Acetate, Aloe Vera Extract

  • Baby Love Diaper Rash Cream Label

    Baby Love

    by Personal Care ™

    Diaper Rash Cream

        with natural zinc oxide
        gentle formula
        hypoallergenic

    maximum rash protection

    NETWT 4.5 OZ (127 g)

    Baby Love ... Baby Pure. Tender skin needs gentle formulation. Our diaper rash cream helps prevent, soothe, and treat diaper rash.

    Distributed by

    PERSONAL CARE PRODUCTS, LLC

    Troy, Michigan 48084 U.S.A.

    Made in India

    PersonalCare DiaperRash Label

  • INGREDIENTS AND APPEARANCE
    BABY LOVE DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-1497
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16.51 g  in 127 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-1497-1127 g in 1 TUBE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2015
    Labeler - Personal Care Products, Inc. (966155082)
    Registrant - Personal Care Products, Inc. (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    anicare pharmaceuticals pvt ltd916837425manufacture(29500-1497)
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