MEIJER ANTIFUNGAL TOLNAFTATE CREAM- tolnaftate cream

Meijer Antifungal Tolnaftate Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient......................... Purpose

Tolnaftate 1%................................Antifungal

PURPOSE

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

Warnings

For external use only

DO NOT USE

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

WHEN USING

When using this product, avoid contact with the eyes.

STOP USE

Stop use and ask a doctor if

• ​irritation occurs
• there is no improvement within 4 weeks

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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.

INDICATIONS & USAGE

Directions

• wash affected area and dry thoroughly
• apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
• supervise children in the use of this product
• for athelete'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 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

DOSAGE & ADMINISTRATION

Other information

• store at room temperature 20-25ºC (68-77ºF)

INACTIVE INGREDIENT

Inactive ingredients cetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, petrolatum, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEIJER ANTIFUNGAL TOLNAFTATE CREAM 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79481-8229
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
SODIUM SULFITE (UNII: VTK01UQK3G)
STEARETH-20 (UNII: L0Q8IK9E08)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79481-8229-1	1 in 1 CARTON	07/16/2020
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	07/16/2020

Labeler - MEIJER, INC. (006959555)