ATOPALM TOLNAFTATE ANTIFUNGAL- tolnaftate cream

ATOPALM TOLNAFTATE ANTIFUNGAL by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Tolnaftate 1%

Purpose

Antifungal

Uses

cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)

helps prevent most athletes foot from recurring when used daily

effectively relieves itching, burning and cracking.

Warnings

For external use only

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

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

Directions

wash affected area and pat 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 a day.

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 not effective on the scalp or nails.

Other Information

store between 20 to 30 C (68 to 86)F

see end of carton or tube crimp for lot number and expiration date.

Inactive Ingredients

Water, glycerin, Cetyl alcohol, mineral oil, PEG-15 Glyeryl Stearate, Glyceryl Stearate, Stearic Acid, Carbomer 94-, Cholesterol, Disodium Phosphate, Myristoyl/Palmitoyl Oxostearamide/Archamide MEA, p-Chloro-m-cresol

Questions?

Call 1-855-ATOPALM

PRINCIPAL DISPLAY PANEL

Relieves itching, burning, cracking of athlete's foot

Effective relief of symptoms of ringworm
Tolnaftate 1%

ATOPALM
Antifungal Cream

with US Patented MLE Technology

Effective Infection Protection for cuts, scrapes and burns

ATOPALM
1% Tolnaftate Antifungal Cream

Cures All Major Types of Athletes Foot Fungus

Net wt. 1oz/28.3g

Distributed by: NeoPharm Co., Ltd 80 Wood Rd, 212 Camarillo, CA 93010

Made in Korea

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ATOPALM TOLNAFTATE ANTIFUNGAL  
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-2000
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
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-15 GLYCERYL STEARATE (UNII: 91245SPD5K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)
PHOSPHATE ION (UNII: NK08V8K8HR)
CHLOROCRESOL (UNII: 36W53O7109)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-2000-1	1 in 1 CARTON
1		28.3 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	03/16/2011

Labeler - Neopharm Co., Ltd. (965502912)

Establishment
Name	Address	ID/FEI	Business Operations
NeoPharm Co., Ltd.		631101883	manufacture(51141-2000)