Tolnaftate Antifungal Cream 1%

Tolnaftate Antifungal by

Drug Labeling and Warnings

Tolnaftate Antifungal by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOLNAFTATE ANTIFUNGAL- tolnaftate cream 
REMEDYREPACK 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.

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Tolnaftate Antifungal Cream 1%

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

Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

DRUG: Tolnaftate Antifungal

GENERIC: Tolnaftate

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-0142-0

COLOR: white

PACKAGING: 15 g in 1 TUBE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

• Tolnaftate 1g in 100g

INACTIVE INGREDIENT(S):

• butylated hydroxytoluene
• titanium dioxide
• petrolatum
• polyethylene glycol 3350
• polyethylene glycol 400

TOLNAFTATE ANTIFUNGAL 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0142(NDC: 51672-2020)
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white (opaque, white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-0142-0	15 g in 1 TUBE; Type 0: Not a Combination Product	01/18/2017	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/18/2017	04/01/2020

Labeler - REMEDYREPACK INC. (829572556)

Revised: 2/2020

Document Id: 9f85767f-01e1-0cc2-e053-2a95a90a9102

34390-5

Set id: 87e9a04f-4724-4da4-85d1-3f2e0e03d137

Version: 2

Effective Time: 20200226

 

REMEDYREPACK INC.