TOLNAFTATE CREAM 1% ANTIFUNGAL- tolnaftate cream 
CARDINAL HEALTH 110 dba LEADER

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Leader Tolnaftate Cream 1% ANTIFUNGAL CREAM

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Anti-Fungal

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

CAH LDR Antifungal Cream 1oz

TOLNAFTATE CREAM 1% ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0084
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0084-11 in 1 BOX02/11/2021
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00502/11/2021
Labeler - CARDINAL HEALTH 110 dba LEADER (063997360)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 1/2024
Document Id: 0dfbb924-3ca1-3df8-e063-6394a90af9ce
Set id: bb14825c-518d-bfba-e053-2995a90a7889
Version: 4
Effective Time: 20240102
 
CARDINAL HEALTH 110 dba LEADER