Label: SALLY HANSEN NO MORE FUNGUS- undecylenic acid liquid

  • 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 October 19, 2021

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  • Active Ingredient

    Undecylenic Acid 25%

  • Purpose

    Antifungal

  • 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
  • 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.

  • Keep out of reach of children.

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

  • 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
  • Other Information

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

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

  • 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

  • PRINCIPAL DISPLAY PANEL

    Outer Package

  • PRINCIPAL DISPLAY PANEL

    Primary

  • INGREDIENTS AND APPEARANCE
    SALLY HANSEN   NO MORE FUNGUS
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID0.23125 g  in 39.01 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66184-151-021 in 1 BOX01/01/2012
    1NDC:66184-151-0139 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2012
    Labeler - Coty US LLC (039056361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Laboratories Inc.001535103manufacture(66184-151)
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