1. Home
  2. Labeler Index
  3. Cardinal Health 110 Dba Leader
  4. 70000-0084
  5. Label Information: Tolnaftate Cream 1% Antifungal

FDA Label for Tolnaftate Cream 1% Antifungal

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. USES
    6. WARNINGS
    7. DIRECTIONS
    8. INACTIVE INGREDIENTS
    9. OTHER INFORMATION
    10. QUESTIONS OR COMMENTS?
    11. DISTRIBUTED BY
    12. PACKAGING

Tolnaftate Cream 1% Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 110 Dba Leader. 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.

Drug Facts




Active Ingredient



Tolnaftate 1%


Purpose



Anti-Fungal


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


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.

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

Do not use on children under 2 years of age except under the advice and supervision of a doctor.


Directions



● wash affected area and dry thoroughly

● apply a thin layer over affected area twice daily (morning and night)

● 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.

● use daily for 4 weeks; if conditions persists longer, ask a doctor.

● to prevent athlete's foot, apply once or twice daily (morning and/or night)

● this product is not effective on the scalp or nails.


Inactive Ingredients



Cetostearyl alcohol, ethylparaben, glycerol, light mineral oil, monostearin, petrolatum, purified water, sodium dodecyl sulfate


Other Information



● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.


* Please review the disclaimer below.