Label: FORMULA 3 - tolnaftate solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/14

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  • FORMULA 3
  • Active ingredient:

    Tolnaftate 1%

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  • Purpose

    Antifungal

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  • Uses:

    For effective treatment of most athlete's foot and ringworm.

    Relieves:

    • Itching
    • Soreness
    • Scaling
    • Burning
    • Cracking
    • Irritation
    • Redness

    Prevents the recurrence of most athlete's foot (dermatophytosis) with daily use.


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  • Warnings

    For external use only.

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

    When using this product avoid contact with eyes.

    Stop use and ask a doctor if

    • When using for athlete's foot or ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
    • When using for the prevention of athlete's foot: If irritation occurs,discontinue use and consult a doctor.

    If pregnant or breastfeeding ask a health professional before use.



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  • Keep out of reach of children.

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

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  • Directions

    For treatment of athlete's foot and ringworm

    • 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 doctor.
    • 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 athlete's foot and ringworm, use daily for 4 weeks.
    • If condition persists longer, consult a doctor. This product is not effective on scalp or nail.

    To prevent athlete's foot:

    • Clean the feet and dry thoroughly.
    • Apply a thin layer of the product to the feet once or twice daily (morning and/or night)
    • Supervise children in the use of this product.
    • Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
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  • Inactive ingredients

    Apricot Kernel Oil, Rice Bran Oil, Sesame Seed Oil, Safflower Oil, Jojoba Oil, Vitamin E Acetate, Methyl Paraben, Propyl Paraben and Butyl Paraben.

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  • FORMULA 3 BRAND Antifungal Tolnaftate 1% Antifungal Solution 15ml (49406-003-15)

    Representative Labeling

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    outer inner label

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  • INGREDIENTS AND APPEARANCE
    FORMULA 3  
    tolnaftate solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49406-003
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    APRICOT KERNEL OIL  
    RICE BRAN OIL  
    SESAME OIL  
    SAFFLOWER OIL  
    JOJOBA OIL  
    .ALPHA.-TOCOPHEROL ACETATE  
    METHYLPARABEN  
    PROPYLPARABEN  
    BUTYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49406-003-15 15 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 10/30/2012
    Labeler - The Tetra Corporation (829958409)
    Registrant - Elba Laboratories (108428483)
    Establishment
    Name Address ID/FEI Business Operations
    Elba Laboratories 108428483 manufacture(49406-003)
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