TOLNAFTATE CREAM 1% ANTIFUNGAL- tolnaftate cream

Tolnaftate Cream 1% ANTIFUNGAL by

Drug Labeling and Warnings

Tolnaftate Cream 1% ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH 110 dba LEADER, Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Anti-Fungal

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.

Questions or Comments?

1-888-296-9067

Distributed By

Distrubuted By Cardinal Health

Dublin, Ohio 43017

www.myleader.com

1-800-200-6313

Essential to Care since 1979

Made in China

2021 Cardinal Health. All rights reserved Cardinal Health, the Cardinal Health LOGO, ESSENTIAL TO CARE and Leader LOGO are trademarks or registered Trademarks of Cardinal Health. All other marks are the property of their respective owners.

All Leader Brand products have a 100% Money Back Guarantee

This product is not manufactured or distributed by Bayer, owner of the registered trademark Tinactin.

Packaging

INGREDIENTS AND APPEARANCE

TOLNAFTATE CREAM 1% ANTIFUNGAL 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0084-1	1 in 1 BOX	02/11/2021
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	02/11/2021

Labeler - CARDINAL HEALTH 110 dba LEADER (063997360)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)