Label: BABY BUTZ- zinc oxide cream

  • NDC Code(s): 52358-0001-1, 52358-0001-2, 52358-0001-3
  • Packager: Olen Skin Care Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 1, 2023

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  • Drug Facts

  • Active Ingredients

    Zinc Oxide 30%

  • Purpose

    Skin Protectant

  • Use

    • Helps treat and prevent diaper rash
    • Protects chafed skin due to diaper rash
    • Helps seal out wetness
  • Warnings

    For External Use Only

  • ASK DOCTOR

    If condition worsen or does not improve within 7 days, consult a physician.

  • When Using this Product

    Avoid Contact with eyes.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center immediately.

  • Directions

    Change wet or 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 any time exposure to wet diaper my be prolonged.

  • Other Information

    Store between 15-30 degrees

  • Inactive Ingredients

    lanolin, petrolatum

  • Questions?

    1-877-494-4313

  • Principal Display Panel

    Baby Butz

    Cream

    Relieves + Prevents

    Diaper Rash

    100% Natural

    30% Zinc Oxide Cream

    Net Wt 4 oz

    NDC 52358-0001-2

    OLEN SKIN CARE CORPORATION

    MB, CANADA

    R2E 0M5

    babybutz.com

    label

  • INGREDIENTS AND APPEARANCE
    BABY BUTZ 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52358-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.1 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52358-0001-157 g in 1 JAR; Type 0: Not a Combination Product11/02/2015
    2NDC:52358-0001-2113 g in 1 JAR; Type 0: Not a Combination Product11/02/2015
    3NDC:52358-0001-3227 g in 1 JAR; Type 0: Not a Combination Product06/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/15/2013
    Labeler - Olen Skin Care Corporation (250916611)
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