WICK STORM TEA TREE ANTIFUNGAL FOOT BODY WASH (TOLNAFTATE) LIQUID [RESTORATION ROCKSTAR LLC]

WICK STORM TEA TREE ANTIFUNGAL FOOT BODY WASH (TOLNAFTATE) LIQUID [RESTORATION ROCKSTAR LLC]
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NDC 69882-025-01
Set ID bea1ec0d-5f38-4126-9502-abe73cb61ad2
Category HUMAN OTC DRUG LABEL
Packager Restoration Rockstar LLC
Generic Name
Product Class
Product Number
Application Number PART333C
  • Drug Facts

  • Active ingredients:

    Tolanaftate    1.0%

    Purpose:

    Antifungal

  • Uses:

    • Proven clinically effective in the treatment of most athlete's foot (tinea pedis) & ringworm (tinea corporis).
    • Helps prevent most athlete's foot with daily use.
    • For effective relief of itching, burning & cracking.
  • Warnings:

    For external use only.

    Do not use

    on children under 2 years of age except under the advice and supervision of a doctor.

    When using this product

    avoid contact with the eyes.

    Stop use and ask a doctor if.

    • Irritation occurs.
    • There is no improvement within 4 weeks.

    Keep out of reach of children.

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

    • Wash affected area and dry thoroughly.
    • Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor.
    • Supervise childern in the use of this product.
    • For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
    • Use daily for 4weeks; if condition persists longer, ask a doctor.
    • Prevent athlete's foot, apply once or twice daily (morning and/or night).
    • This product is not effective on the scalp or nails.
  • Inactive ingredients:

    Acrylates copolymer, aqua (deionized water), cocamide MEA,cocamidopropyl betaine, disodium oleamido MEA sulfosuccinate, dl-panthenol, DMDM hydantion, glycol stearate, isopropyl myristate, melaleuca alternaifolia (australian tea tree) leaf oil, mentha piperita (peppermint) oil, origanum vulgare (oregano) leaf oil, sodiu, laureth sulfate, sodium lauryl sulfate, triethanolamine.

  • Other information

    Store betbeen 20​​ to 25C (68 to 77F)

  • Product Label

    carton

  • INGREDIENTS AND APPEARANCE
    WICK STORM TEA TREE ANTIFUNGAL FOOT BODY WASH 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69882-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DISODIUM OLEAMIDO MEA-SULFOSUCCINATE (UNII: 5M1101WGSY)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69882-025-01266.16 mL in 1 BOTTLE; Type 0: Not a Combination Product07/10/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/10/2015
    Labeler - Restoration Rockstar LLC (071268228)

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