Label: BABY BUM- zinc oxide and lanolin paste

  • 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 December 18, 2019

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  • Active ingredients

    Zinc Oxide 12.5%

    Lanolin USP 50%

  • Uses

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

    Skin Protectant

    Skin Protectant

  • Warnings

    • For external use only
    • When using this product avoid contact with eyes
    • Stop use and ask a doctor if conditions worsens or does not improve after 7 days
    • If swallowed, seek medical help or call Poison Control Center immediately

    • Keep out of the reach of children to prevent accidental indigestion
  • Directions

    • Change wet or soiled diaper immediately
    • Cleanse the diaper area and allow to dry
    • Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime
  • Other Information

    • Store at room temperature, 20°C to 27°C (68° to 80°F)
  • Inactive Ingredients

    • Starch, White Petrolatum
  • Questions or Comments

    Address 1790 Blairs Ferry Rd, Hiawatha, IA 52233

    Website www.babybumpaste.com

  • Principal Display Panel

    babybum-pic

  • INGREDIENTS AND APPEARANCE
    BABY BUM 
    zinc oxide and lanolin paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72997-808
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.125 g  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN0.5 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72997-808-09113.4 g in 1 JAR; Type 0: Not a Combination Product06/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/26/2019
    Labeler - Blairs Ferry Pharmacy (001360804)
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