Label: HOMEHEALTH ANTIFUNGAL- tolnaftate lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient                                                           Purpose

    Tolnaftate 1.0%..........................................................Antifungal

  • PURPOSE

    Uses

    - proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm with daily use.  - helps prevent most athlete's foot with daily use.  - for effective relief of itching, burning and cracking.

  • WARNINGS

    Warnings      For external use only.

  • INDICATIONS & USAGE

    When using this product avoid contact with eyes.

  • STOP USE

    Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch.  Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks for athlete's foot or ringworm.

  • DO NOT USE

    Do not use on children under 2 years of age unless directed by a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    - clean 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 physician; - supervise children in the use of this product; - for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. - for jock itch, use daily for 2 weeks. - for athlete's foot and ringworm, use daily for 4 weeks. - if condition persists longer, consult a doctor. - this product is not effective on the scalp or nails.

  • STORAGE AND HANDLING

    Other information      store in a cool, dry place.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Almond oil, aloe vera gel, calendula oil, castor oil, cetyl alcohol, citricidal (grapefruit seed extract), cocoa butter, diazolidinyl urea, lanolin oil, lavender oil, methylparaben, myrrh tincture, propylene glycol, propylparaben, rosemary oil, stearic acid, tea tree oil, thyme oil, triethanolamine, water.

  • DESCRIPTION

    Antifungal Lotion provides effective relief of itching, scaling, burning, irritation and discomfort associated with athlete's foot, jock itch and ringworm.  The active ingredient, Tolnaftate, combines with a soothing base of natural botanical extracts to yield a truly unique formula.  You can count on Home Health to deliver the natural heath products your family deserves.  No Mineral Oil, No petroleum, No Artificial Colors, No Artificial Fragrance.  Carefully Manufactured for  HomeHealth, Co. Ronkonxoma, NY 11779 U.S.A. 800-445-7137 www.HomeHealthUS.com 2009 Home Health  B11812 03B

  • PRINCIPAL DISPLAY PANEL

    HomeHealth  Natural Health Begins at Home  Antifungal Lotion  Tolnaftate  Proven Clinicallyl Effective In the Threatment of Most Athlete's Foot, Jock Itch, Ringworm    Net Wt. 4 fl. oz. (118mL)

  • PRINCIPAL DISPLAY PANEL

    Antifungal Lotion

  • INGREDIENTS AND APPEARANCE
    HOMEHEALTH ANTIFUNGAL 
    tolnaftate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76020-100
    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
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    THYME OIL (UNII: 2UK410MY6B)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76020-100-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/14/2011
    Labeler - Home Health (052609675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(76020-100)