UNDECYLENIC ACID LIQUID [RITEAID]

UNDECYLENIC ACID LIQUID [RITEAID]
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NDC 11822-0028-7
Set ID f18d11d7-e8cf-42a3-b618-f14f92d03289
Category HUMAN OTC DRUG LABEL
Packager RiteAid
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID288 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) 712 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0028-71 in 1 CARTON
    130 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C06/01/2008
    Labeler - RiteAid (014578892)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture

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