Country: United States
Language: English
Source: NLM (National Library of Medicine)
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)
The Podiatree Company
TOPICAL
OTC DRUG
Antifungal • cures most athlete’s foot infections and ringworm infections • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions on children under 2 years of age unless directed by a doctor. When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. • irritation occurs • there is no improvement within 4 weeks
OTC monograph final
FORTINIA OF- CLOTRIMAZOLE 1% SOLUTION THE PODIATREE COMPANY _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 Clotrimazole 1% PURPOS E Antifungal US ES • cures most athlete’s foot infections and ringworm infections • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions WARNINGS For external use only FLAMMABLE Do not use near heat or ame, or while smoking. Cap tightly and store at room temperature away from heat. DO NOT USE on children under 2 years of age unless directed by a doctor. When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. STOP USE AND ASK A DOCTOR OR PHARMACIST IF • irritation occurs • there is no improvement within 4 weeks KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately. DIRECTIONS • wash affected area and dry thoroughly • apply one drop to the affected area twice daily (morning and night) or as directed by your doctor • using a disposable cotton swab, spread a thin layer over the affected area • discard cotton swab • supervise children in the use of this product • for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily • for athlete’s foot and ringworm infections, use daily for 4 weeks • this product is not effective on scalp or nails OTHER INFORMATION Store at controlled room temperature. INACTIVE INGREDIENTS Ethyl Alcohol (79%), Propylene Glycol QUESTIONS OR SUGGESTIONS? 1.855.763.8733 or visit us at www.thepodiatreecompany.com PRINCIPAL DISPLAY PANEL The Podiatree Company FORTINIA OF clotrimazole 1% solution PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:546 33-0 17 ROUTE OF ADMINISTRATION TOPICA Read the complete document