SALLY HANSEN NO MORE FUNGUS (UNDECYLENIC ACID) LIQUID [COTY US LLC]

SALLY HANSEN NO MORE FUNGUS (UNDECYLENIC ACID) LIQUID [COTY US LLC]
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NDC 66184-151-01, 66184-151-02
Set ID 9f12bfcb-c0f5-4113-996c-917976c01349
Category HUMAN OTC DRUG LABEL
Packager Coty US LLC
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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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