Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)
REMEDYREPACK INC.
TOPICAL
OTC DRUG
Uses - proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) - proven effective in the prevention of athlete's foot with daily use - for effectively relief of itching, burning and cracking 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) 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 - use daily for 4 week; if condition persists longer, ask a doctor - this product is not effective on the scalp or nails
OTC monograph final
LEADER ANTIFUNGAL TOLNAFTATE- TOLNAFTATE CREAM REMEDYREPACK INC. _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- ACTIVE INGREDIENT PURPOSE Tolnaftate 1%.........................................................Antifungal US ES proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) proven effective in the prevention of athlete's foot with daily use for effectively 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. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Wash affected area and dry thoroughly Apply a thin layer 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 use daily for 4 week; if condition persists longer, ask a doctor this product is not effective on the scalp or nails OTHER INFORMATION store between 20 to 25 C (68 to 77 F) Lot No. & Exp. Date: see box or see crimp of tube INACTIVE INGREDIENTS butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, prolyoxyethylene cetyl ether, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Made in Korea o o o o DRUG: LEADER ANTIFUNGAL TOLNAFTATE GENERIC: TOLNAFTATE DOSAGE: CREAM ADMINSTRATION: TOPICAL NDC: 70518-0794-0 PACKAGING: 28 g in 1 TUBE ACTIVE Lesen Sie das vollständige Dokument