Label: MEDICATED CORNSTARCH BABY POWDER- active corn starch powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 28, 2024

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  • Active Ingredients

    Corn Starch 79%

    Kaolin 4%

    Zinc Oxide 15%

  • Purposes

    Skin Protectant

  • Uses

    • Prevents chafed skin and reduces minor skin irritations due to diaper rash
    • Helps protect from wetness
  • Warnings

    For external use only.

    When using this product

    • Avoid contact with eyes
    • Do not use on broken skin
    • Keep powder away from child's face to avoid inhalation which can cause breathing problems

    Stop use and ask a doctor if

    • If conditions worsen or symptoms do not get better within 7 days

    Keep out of reach of children.

    If ingested, get medical help or contact a Poison Control Center immediately.

  • Directions

    Babies: Change wet and soiled diaper promptly, cleanse the diaper area and allow to dry.  Apply powder liberally as often as necessary, with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged.  Apply powder close to the body away from child's face.  Carefully shake the powder into the diaper or into the hand and apply to diaper area.  

    Adults and children 2 years and older: apply freely up to 3 or 4 times daily.  For best results, dry skin thoroughly before applying.

  • Inactive ingredients

    Fragrance, Silica

  • PRINCIPAL DISPLAY PANEL

    Medicated Cornstarch Baby Powder

  • INGREDIENTS AND APPEARANCE
    MEDICATED CORNSTARCH BABY POWDER 
    active corn starch powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42669-231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STARCH, CORN (UNII: O8232NY3SJ) (STARCH, CORN - UNII:O8232NY3SJ) STARCH, CORN89.27 g  in 113 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16.95 g  in 113 g
    KAOLIN (UNII: 24H4NWX5CO) (KAOLIN - UNII:24H4NWX5CO) KAOLIN4.52 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42669-231-04113 g in 1 BOX; Type 0: Not a Combination Product09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/01/2016
    Labeler - Davion, Inc. (174542928)
    Registrant - Davion, Inc. (079536689)
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