KAISER PERMANENTE TOLNAFTATE- tolnaftate cream
Kaiser Foundations Hospitals

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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Kaiser Permanente ®

Tolnaftate

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

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 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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 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

Other information

store between 20° to 25°C (68° to 77°F)
see carton or tube crimp for lot number and expiration date

Inactive ingredients

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

Questions?

Call 1-866-923-4914

Manufactured by
Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Distributed by
Kaiser Foundation Hospitals, Livermore, CA 94551-9756

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

KAISER PERMANENTE ®

Tolnaftate Cream 1%

ANTIFUNGAL CREAM

CURES & PREVENTS MOST ATHLETE'S FOOT

*Compare to the active ingredient in Tinactin ®

NET WT 1 OZ (30 g)

Principal Display Panel - 30 g Tube Carton

KAISER PERMANENTE TOLNAFTATE
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0179-8019
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0179-8019-30	1 in 1 CARTON	02/17/2006	03/31/2022
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	02/17/2006	03/31/2022

Labeler - Kaiser Foundations Hospitals (053052619)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	manufacture(0179-8019)

Revised: 11/2018

Document Id: 7ad200db-c8fb-f509-e053-2991aa0a9561

Set id: 603fd22b-1f82-4eb3-b956-1022c87776ee

Version: 3

Effective Time: 20181116

Kaiser Foundations Hospitals

Kaiser Permanente ® Tolnaftate