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Undesine (Indiana Botanic Gardens)

Available Formats

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OINTMENT 29 g in 1 JAR (10578-009-01) Label Information

Complete Undesine Information

  • ACTIVE INGREDIENT

    Active Ingredient

    Undecylenic acid    5%

    Zinc undecylenate  20%





  • PURPOSE

    Purpose

    topical antifungal

    topical antifungal


  • INDICATIONS & USAGE

    Uses:

    • cures athletes foot (dermatophytosis)
    • clears up ringworm (tinea corporis)
    • cures jock itch (tinea cruris)

  • WARNINGS

    Warnings: For external use only.

    Avoid contact with the eyes.


    Do not use:

    • on children under 2 years of age
    • for diaper rash
    • on scalp or nails


  • ASK DOCTOR

    Stop using and ask a doctor if

    • irritation occurs
    • if no improvement within 4 weeks

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


  • DOSAGE & ADMINISTRATION

    Directions:

    • clean the affected area and dry thoroughly
    • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
    • supervise children in the use of this product
    • For athlete's foot: pay special attention to spaces between the toes, wear well fitting, ventilated shoes, and change shoes and socks at least once daily
    • use for 4 weeks. (for athlete's foot and ringworm)
    • for jock itch: use daily for 2 weeks


  • QUESTIONS


    Other information:

    To reorder call: 1-800-644-8327

    website: www.botanicchoice.com

    Use only of seal is unbroken


  • SPL UNCLASSIFIED SECTION

    Manufactured by: Indiana Botanic Gardens, Inc.

    NDC# 1057800901


  • INACTIVE INGREDIENT

    Inactive ingredients: light mineral oil, white petrolatum, methylparaben


  • INGREDIENTS AND APPEARANCE
    UNDESINE 
    undecylenic acid, zinc undecylenate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10578-009
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 5 g  in 100 g
    ZINC UNDECYLENATE (UNII: 388VZ25DUR) (ZINC UNDECYLENATE - UNII:388VZ25DUR) ZINC UNDECYLENATE 20 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10578-009-01 29 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 01/01/1995
    Labeler - Indiana Botanic Gardens (005421771)
    Registrant - Indiana Botanic Gardens (005421771)
    Establishment
    Name Address ID/FEI Business Operations
    Indiana Botanic Gardens 005421771 label, manufacture