THERA PLUS ANTIFUNGAL TOLNAFTATE- tolnaftate cream

Thera plus Antifungal Tolnaftate by

Drug Labeling and Warnings

Thera plus Antifungal Tolnaftate by is a Otc medication manufactured, distributed, or labeled by FOURSTAR GROUP USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Anti-Fungal

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.

Do not use

on children under 2 years of age except under the advice and supervision of a doctor.

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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

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-ftting, 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 at room temperature 20° to 25°C (68° to 77°F)
• lot no & expiration date: see box or crimp of tube

Inactive ingredients

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

Questions?

1-888-296-9067 Weekdays 9 AM to 4 PM EST

Package Labeling:

INGREDIENTS AND APPEARANCE

THERA PLUS ANTIFUNGAL TOLNAFTATE 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-040
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
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-040-01	1 in 1 BOX	01/30/2022
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 Drug	M005	01/30/2022

Labeler - FOURSTAR GROUP USA, INC. (140099503)