FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]

FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]
PDF | XML

NDC 49406-003-15
Set ID 0895274b-a09d-4264-a43f-852e44eb3163
Category HUMAN OTC DRUG LABEL
Packager The Tetra Corporation
Generic Name
Product Class
Product Number
Application Number PART333C
  • FORMULA 3

  • Active ingredient:

    Tolnaftate 1%

  • Purpose

    Antifungal

  • 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.


  • 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.



  • Keep out of reach of children.

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

  • 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.
  • 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.

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

    Representative Labeling

    outer label

    outer inner label

    inner label

  • INGREDIENTS AND APPEARANCE
    FORMULA 3 
    tolnaftate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49406-003
    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
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    SESAME OIL (UNII: QX10HYY4QV)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    JOJOBA OIL (UNII: 724GKU717M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49406-003-151 in 1 BOX10/30/2012
    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 finalpart333C10/30/2012
    Labeler - The Tetra Corporation (829958409)
    Registrant - The Tetra Corporation (829958409)