Label: UNDESINE- undecylenic acid, zinc undecylenate ointment

  • 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 1, 2010

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  • 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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