Country: United States
Language: English
Source: NLM (National Library of Medicine)
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)
Pedinol Pharmacal, Inc.
TOLNAFTATE
TOLNAFTATE 1 g in 100 g
TOPICAL
OTC DRUG
Antifungal
OTC monograph final
FUNGOID-D- TOLNAFTATE CREAM PEDINOL PHARMACAL, 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._ ---------- _DRUG FACTS_ _ACTIVE INGREDIENT_ Tolnaftate 1% _PURPOSE_ Antifungal _USES_ • • _WARNINGS_ FOR EXTERNAL USE ONLY DO NOT USE on children under 2 years of age unless directed by a doctor. WHEN USING THIS PRODUCT • • KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ • • • • _OTHER INFORMATION_ Store at controlled room temperature 15°- 30°C (59°- 86°F). _INACTIVE INGREDIENTS_ prevents the recurrence of most athlete's foot (tinea pedis) with daily use. clears up most athlete's foot infection and with daily use helps keep it from coming back. avoid contact with the eyes. if irritation occurs, discontinue use and consult a doctor. 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. aloe barbadensis (aloe vera) leaf juice, beeswax, cetyl alcohol, citric acid, diazolidinyl urea, DMDM hydantoin, melaleuca alternifolia (tea tree) flower/leaf/stem extract, methylparaben, microcrystaline wax, mineral oil, propylene glycol, propylparaben, sodium lauryl sulfate, stearyl alcohol, triethanolamine, urea, water _QUESTIONS OR COMMENTS?_ Please call 1-800-321-4576 Monday - Friday, 9 AM until 5 PM EST, except holidays or visit us online at www.pedinol.com. PRINCIPAL DISPLAY PANEL - 4 OZ. (113 G) CARTON NDC 0884-8211-04 PEDINOL® fungoid-D™ tolnaftate 1% ANTIFUNGAL CREAM IN A MOISTURIZING BASE prevents most athlete's foot & hydrates dry skin with daily use Net. wt. 4 oz. (113 g) FUNGOID-D tolnaftate cream Read the complete document