ANTIFUNGAL CREAM TOLNAFTATE 1%- tolnaftate cream

Antifungal Cream Tolnaftate 1% by

Drug Labeling and Warnings

Antifungal Cream Tolnaftate 1% by is a Otc medication manufactured, distributed, or labeled by Meijer, Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

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

Do Not Use

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Stop Use and Ask a Doctor if

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks

If Pregnant or Breast-feeding

If Pregnant or Breast-feeding ask a health professional before use

Inactive ingredients

Cetostearyl alcohol, ethylparaben, glycerol, mineral oil, glyceryl monostearate, petrolatum, purified water, sodium lauryl sulfate

Directions

● wash affected area and dry thoroughly

● apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor

● 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.

● for athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult 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)

Questions or Comments?

1-888-296-9067

Distributed By

Distrubuted By Meijer Distribution, Inc.

Grand Rapids, MI 49544

www.meijer.com

Made in China

This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademarks Tough Actin and Tinactin.

Packaging

INGREDIENTS AND APPEARANCE

ANTIFUNGAL CREAM TOLNAFTATE 1% 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79481-0015
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: 79481-0015-5	1 in 1 BOX	05/12/2021
1		14 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 final	part333C	05/12/2021

Labeler - Meijer (006959555)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)