Label: SALLY HANSEN NO MORE FUNGUS- undecylenic acid liquid

  • NDC Code(s): 66184-151-01, 66184-151-02
  • Packager: Coty US LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Undecylenic Acid 25%

    Close
  • Purpose

    Antifungal

    Close
  • Uses

    cures most ringworm (tinea corporis) and athlete's foot (tinea pedis).

    Soothes:

    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomfort
    • itchy, scaling skin between the toes
    • itching, burning feet
    Close
  • Warnings

    For external use only

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

    Avoid contact with eyes.

    Stop use and ask a doctor if:

    • irritation occurs
    • there is not improvement within 4 weeks.

    Close
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • Directions

    Use daily for 4 weeks. This product is not effective on the scalp or nails.

    • wash 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, veniltated shoes
    • change shoes and socks at least once daily
    Close
  • Other Information

    • do not use if the printed seal is broken or missing prior to opening
    • keep away from direct sunlight
    Close
  • Inactive ingredients

    proplylene glycol dicaprylate/dicaprate, parfum/fragrance, limonene, linalool

    Close
  • Questions or comments?

    To report a serious adverse event and for informaiton or comments on this product call us at 1-800-953-5080

    9:00AM-5:00PM EST or visit www.sallyhansen.com

    Close
  • INGREDIENTS AND APPEARANCE
    SALLY HANSEN  NO MORE FUNGUS
    undecylenic acid liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66184-151
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID 0.23125 g  in 39.01 mL
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL DICAPRYLATE  
    LIMONENE, (+)-  
    LINALOOL, (+)-  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66184-151-02 1 in 1 BOX
    1 NDC:66184-151-01 39.0 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 01/01/2012
    Labeler - Coty US LLC (789573201)
    Establishment
    Name Address ID/FEI Business Operations
    Kolmar Laboratories Inc. 001535103 manufacture(66184-151)
    Close