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Baby Anti Monkey Butt Diaper Rash (DSE Healthcare Solutions, LLC.)

Available Formats

Dosage Form Package Information Links
POWDER 170 g in 1 BOTTLE (42364-0013-0) Label Information

Complete Baby Anti Monkey Butt Diaper Rash Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredients

    Calamine Powder 8.0%                                          


  • Purpose

    Skin Protectant


  • Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin and 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
    • Condition worsens
    • Symptoms do not get better within 7 days

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact Poison Control center right away.


  • Directions

    • Adults and children 2 years and older: apply freely up to 3 or 4 times daily. For best results, dry skin thoroughly before applying.
    • 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 diaper may be prolonged. Apply powder close to the body away from the child’s face. Carefully shake the powder into the diaper or into the hand and apply to the diaper area.

  • Inactive Ingredients

    Cornstarch, fragrance, tricalciumphosphate


  • PRINCIPAL DISPLAY PANEL

    Tender Loving Care for
    Your Baby’s Derrière
    Helps Prevent & Treat
    Diaper Rash       Chafing
    Minor Skin Irritations
    Helps Protect from Wetness
    Baby
    Anti Monkey
    Butt®
    Diaper Rash Powder
    with Calamine
    Helps Treat and Prevent Diaper Rash
    NET WT 6oz (170g)
    PRINCIPAL DISPLAY PANEL
Baby Anti Monkey Butt Diaper Rash Powder


  • INGREDIENTS AND APPEARANCE
    BABY ANTI MONKEY BUTT DIAPER RASH  
    ferric oxide red and zinc oxide powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42364-0013
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.076 g  in 1 g
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 0.004 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42364-0013-0 170 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 04/18/2012
    Labeler - DSE Healthcare Solutions, LLC. (603016069)
    Establishment
    Name Address ID/FEI Business Operations
    PTI Union LLC 807308858 MANUFACTURE(42364-0013)
    Establishment
    Name Address ID/FEI Business Operations
    Thornton Industries, Inc. 614259299 MANUFACTURE(42364-0013)