Label: GOOD NEIGHBOR ANTI-FUNGAL- undecylenic acid liquid

  • Category: HUMAN OTC DRUG LABEL

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 June 27, 2013

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  • Active ingredient

    Undecylenic Acid, 25% w/v

  • Purpose

    Anti-fungal

  • Uses

    For the cure of most ringworm (tinea corporis) and athlete's Foot (tinea pedis).  For relief of itching, scaling , cracking, burning, redness, soreness, irritation, and discomfort which accompany these conditions.

  • Warnings

    For external use only

  • DO NOT USE

    Do not use on children under 2 years of ae unless directed by a doctor.

  • WHEN USING

    When using this product avoid contact with eyes

  • STOP USE

    Stop use and consult a doctor if irritation occurs or if there is no improvement within 4 weeks.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Read all package directions and warnings before using.
    • Use only as directed.
    • Clean affected area with soap and warm water and dry thoroughly.
    • Apply a thin layer of Anti-Fungal Liquid over the affected area twice daily (morning and night) or as directed by a doctor.
    • For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily
    • For athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
    • Intended for use by normally healthy adults only.
    • Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
    • Supervise shildren in the use of this product
    • This product is not effective on scalp or nails.
  • Other information

    • keep thighly closed when not in use
    • store away from excessive heat and cold
  • Inactive ingredients

    aloe vera gel, fragrance, hypromellose, isopropyl alcohol (70% v/v), water, vitamin E

  • PRINCIPAL DISPLAY PANEL

    image of label

    image of carton

  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR ANTI-FUNGAL 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-676
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID250 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    isopropyl alcohol (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-676-301 in 1 CARTON
    1NDC:24385-676-3130 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/01/2008
    Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) (007914906)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    NameAddressID/FEIBusiness Operations
    AmerisourceBergen Drug Corporation007914906label(24385-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lee Pharmaceuticals056425432pack(24385-676)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack009248480manufacture(24385-676)