FUNGABLEND 10 (TOLNAFTATE) LIQUID [HAPPY FOOT SHOP, LLC]

FUNGABLEND 10 (TOLNAFTATE) LIQUID [HAPPY FOOT SHOP, LLC]
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NDC 69983-026-01
Set ID 02bec15c-beab-4748-86ad-7a2d76a2607e
Category HUMAN OTC DRUG LABEL
Packager Happy Foot Shop, LLC
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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 scalp or nails
  • Inactive ingredients:

    Ageratina sp. (snakeroot) extract, aloe barbadensis (aloe vera gel) juice, aqua (deionized water), butylene glycol, C13-14 isoparaffin, citrus grandis (grapefruit) fruit extract, citrus medica limonum (lemon) peel oil, ethylhexylglycerin, laureth-7, lavandula officinalis (lavender) oil, melaleuca alternifolia (australia tea tree) leaf oil, origanum vulgare (oregano) leaf oil, phenoxyethanol, polyacrylamide, polysorbate-20, prunus amygdalus dulcis (almond) oil, rosmarinus officinalis (rosemary) leaf extract, SD-alcohol 40B, simmondsia chinensis (jojoba) seed oil, theobroma cacao (cocoa) butter, thymus vulgaris (thyme) extract, tocopheryl acetate (vitamin e), urea.

  • Other information

    Store between 20 ​o ​to 25 ​o​ C (68​ ​o ​​to 77 ​o​ F)

  • Product Label

    Carton

  • INGREDIENTS AND APPEARANCE
    FUNGABLEND 10 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69983-026
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PUMMELO (UNII: ET1TN5W71X)  
    LEMON OIL (UNII: I9GRO824LL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LAURETH-7 (UNII: Z95S6G8201)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ROSEMARY (UNII: IJ67X351P9)  
    ALCOHOL (UNII: 3K9958V90M)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    THYME (UNII: CW657OBU4N)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69983-026-011 in 1 CARTON02/23/2017
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/09/2015
    Labeler - Happy Foot Shop, LLC (079776150)

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