Tolnaftate by NeoPharm Co., Ltd. TOLNAFTATE cream

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by NeoPharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Antifungal

Uses

• clinically proven to cure most athlete's foot (tinea pedis) and ringworm (tinea corporis)
• helps prevnet most athlete's foot from recurring when used daily
• effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking
  

Warning

For external use only

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
  

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 of twice daily (morning and/or night)
• this product is not effective on the scalp or nails
  

Other Information

• store between 2° and 30°C (36° and 86°F)

Inactive ingredients

Carbomer, Cetyl alcohol, Cholesterol, Dibasic sodium phosphate hydrate, Glycerin, Glyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Water

Principal Display Panel

Tolnaftate

Active Ingredients

Tolnaftate 1%

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-0057
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
Alcohol (UNII: 3K9958V90M)
Glycerin (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Paraffin (UNII: I9O0E3H2ZE)
Stearic acid (UNII: 4ELV7Z65AP)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-0057-1	1 in 1 BOX
1		28 g in 1 TUBE
2	NDC: 51141-0057-6	1 in 1 BOX
2		20 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/27/2010

Labeler - NeoPharm Co., Ltd. (631101883)

Registrant - NeoPharm Co., Ltd. (631101883)

Establishment
Name	Address	ID/FEI	Business Operations
NeoPharm Co., Ltd.		631101883	manufacture