UNDESINE (UNDECYLENIC ACID, ZINC UNDECYLENATE) OINTMENT [INDIANA BOTANIC GARDENS]

UNDESINE (UNDECYLENIC ACID, ZINC UNDECYLENATE) OINTMENT [INDIANA BOTANIC GARDENS]
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NDC 10578-009-01
Set ID 730ecb18-b67f-403f-95db-1fb79f06d61d
Category HUMAN OTC DRUG LABEL
Packager Indiana Botanic Gardens
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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

  • PRINCIPAL DISPLAY PANEL

    picture of label

  • INGREDIENTS AND APPEARANCE
    UNDESINE 
    undecylenic acid, zinc undecylenate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID5 g  in 100 g
    ZINC UNDECYLENATE (UNII: 388VZ25DUR) (ZINC UNDECYLENATE - UNII:388VZ25DUR) ZINC UNDECYLENATE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10578-009-0129 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/1995
    Labeler - Indiana Botanic Gardens (005421771)
    Registrant - Indiana Botanic Gardens (005421771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Indiana Botanic Gardens005421771label, manufacture

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