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  5. Label Information: Tm -tolnaftate

FDA Label for Tm -tolnaftate

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. QUESTIONS?
    9. PRODUCT LABEL

Tm -tolnaftate Product Label

The following document was submitted to the FDA by the labeler of this product Singular Dreamer, Ltd Dba True Marker. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Tolnaftate 1%


Purpose



Topical Antifungal


Uses



  • Proven clinically effective in the treatment of most fungal infections including related/associated to tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm)
  • For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections
  • Prevents most tinea pedis (athlete’s foot) 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 irritation occurs of if there is no improvement within 4 weeks, discontinue use and consult a doctor (within 2 weeks for jock itch)
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • If pregnant or breast-feeding, ask a health professional before use.

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 doctor
  • Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • 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 the scalp or nails.

Other Information



Protect the product in this container from excessive heat and direct sun.


Inactive Ingredients



Helianthus Annuus (Sunflower) Oil, Vitis Vinifera (Grape) Seed Oil, Mentha Piperita (Peppermint) Oil, Tocopheryl Acetate (Vitamin E), BHT (Butylated hydroxytoluene)


Questions?



304-742-2433


Product Label



image description - Label 1260

image description - Label 1260


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