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UNDECYLENIC ACID (CVS Pharmacy)

Available Formats

Dosage Form Package Information Links
LIQUID 1 BOTTLE, WITH APPLICATOR in 1 CARTON (59779-132-15) > 30 mL in 1 BOTTLE, WITH APPLICATOR Label Information

Complete UNDECYLENIC ACID Information

  • ACTIVE INGREDIENT

    Section from Carton Label Follows:

    Active ingredient                      Purpose
    Undecylenic acid 25% w/v.......Antifungal
  • PURPOSE

    Section from Carton Label Follows:

    Active ingredient                       Purpose
    Undecylenic Acid 25% w/v.................Antifungal

    Uses
    Treats most athletes foot (tinea pedis)
    and ringworm (tinea corporis)
  • KEEP OUT OF REACH OF CHILDREN

    Section from Warnings section of Carton label follows:

    KEEP THIS AND ALL MEDICATION OUT
    OF THE REACH OF CHILDREN

    If accidental ingestion occurs,
    immediately contact a physician,
    emergency medical facility or Poison
    Control Center for help.

  • INDICATIONS & USAGE

    Section from Directions portion of carton label follows:

    Directions
    - Using soap and water, 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.
    - Use the brush applicator provided for
    easy application to the affected area
    - For toe usage, change shoes and socks
    at least once daily and wear well fitting,
    ventilated shoes
    - Pay particular attention to spaces
    between the toes for athletes foot
    - For athletes foot and ringworm, use the
    product daily for 4 weeks. If condition
    persists longer, consult a physician
    - This product is not effective on the scalp
    or nails
    - Children must be supervised in the use
    of this product


  • WARNINGS

    From Warnings Section of Carton Label:

    Warnings For external use only.
    ______________________________
    Ask a doctor before use on children
    under 2 years of age
    ____________________________________
    When using this productavoid contact
    with the eyes
    ____________________________________
    Stop use and consult a doctor if
    - Irritation occurs - you do not notice
    improvement within 4 weeks
    ____________________________________
    KEEP THIS AND ALL MEDICATION OUT
    OF THE REACH OF CHILDREN
    If accidental ingestion occurs,
    immediately contact a physician,
    emergency medical facility or Poison
    Control Center for help.

  • DOSAGE & ADMINISTRATION

    Section from Directions portion of carton label follows:

    Directions
    - Using soap and water, 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.
    - Use the brush applicator provided for
    easy application to the affected area
    - For toe usage, change shoes and socks
    at least once daily and wear well fitting,
    ventilated shoes
    - Pay particular attention to spaces
    between the toes for athletes foot
    - For athletes foot and ringworm, use the
    product daily for 4 weeks. If condition
    persists longer, consult a physician
    - This product is not effective on the scalp
    or nails
    - Children must be supervised in the use
    of this product


  • INACTIVE INGREDIENT

    From Inactive Ingredients section of Carton Label:

    Inactive Ingredients Isopropyl Palmitate

  • PRINCIPAL DISPLAY PANEL

    Carton
    carton



  • INGREDIENTS AND APPEARANCE
    UNDECYLENIC ACID 
    undecylenic acid liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-132
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID 288 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 712 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-132-15 1 in 1 CARTON
    1 30 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 06/01/2008
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    Name Address ID/FEI Business Operations
    Pharma Pac, LLC 140807475 manufacture