Label: SIGNATURE BLACK BOTTLE TEA TREE ANTIFUNGAL FOOT AND BODY WASH- tolnaftate lotion

  • NDC Code(s): 69882-726-01
  • Packager: Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Drug Facts

  • Active ingredients:

    Tolnaftate 1.0%

    Purpose:

    Antifungal

  • Uses

    • Proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • Helps prevent most athlete's foot with daily use
    • For effective relief of itching, burning and 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 children 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 4 weeks; 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 hydantoin, glycol stearate, isopropyl myristate, melaleuca alternifolia (australian tea tree) leaf oil, mentha piperita (peppermint) oil, origanum vulgare (oregano) leaf oil, sodium laureth sulfate, sodium lauryl sulfate, triethanolamine.

  • Other information

    Store between 20° to 25°C (68° to 77°F)

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SIGNATURE BLACK BOTTLE TEA TREE ANTIFUNGAL FOOT AND BODY WASH 
    tolnaftate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69882-726
    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 MONOETHANOLAMINE 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:69882-726-01266.16 mL in 1 BOTTLE; Type 0: Not a Combination Product02/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/10/2016
    Labeler - Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle) (071268228)
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