ATHLETES FOOT- tolnaftate cream 
Kroger 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.

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Kroger Co. Athlete's Foot Cream Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

proven clinically effective in the treatment of most
athlete’s foot (tinea pedis)
ringworm (tinea corporis)
helps prevent most athlete’s foot with daily use
for effective relief of
itching
burning
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 unless directed by a doctor

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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 condition lasts 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

Other information

store at 68°-77°F (20°-25°C)

Inactive ingredients

butylated hydroxytoluene, carbomer homopolymer, monoamylamine, PEG-400, propylene glycol, titanium dioxide

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of TINACTIN® ANTIFUNGAL CREAM

See bottom panel

Athlete’s Foot Cream

Tolnaftate 1%

ANTIFUNGAL CREAM

Cures & Prevents Most Athlete’s Foot

Effective Relief of Itching & Burning

Greaseless, Odorless

NET WT 0.5 OZ (14 g)

Kroger Co. Athlete's Foot Cream
Kroger Co. Athlete's Foot Cream
ATHLETES FOOT 
tolnaftate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-533
Route of Administration TOPICAL DEA Schedule     
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PENTYLAMINE (UNII: E05QM3V8EF)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:30142-533-58 1 in 1 CARTON
1 14 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 01/26/2012
Labeler - Kroger Company (006999528)

Revised: 11/2013
Document Id: dea12fc8-cd7f-407e-8f66-0edbaec4ca3b
Set id: 211b1f78-7b34-4a07-b17b-04a4b369f1d9
Version: 2
Effective Time: 20131111
 
Kroger Company