Tolnaftate by Morales Distributors, Inc. TOLNAFTATE cream

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Morales Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each gram)

Tolnaftate 1 percent

Purpose

Antifungal

Uses

• clinically proven to cure most athlete's foot (tinea pedis) and ringworm (tinea corporis)
• helps prevent most athlete's foot from recurring when used daily
• effectively soothes and relieves symptoms of athlete's foot, including 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
• 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 attentional 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 or twice daily (morning and night)
• this product is not effective on the scalp or nails
  

Other information

store between 2 degrees and 30 degrees Celsius (36 degrees and 86 degrees Fahrenheit)

Inactive ingredients

carbomer 940, cetyl alcohol, chlorocresol, dibasic sodium phosphate hydrate, glycerin, glyceryl monostearate, light liquid paraffin, purified water, and stearic acid

Package label

NDC NO. 53210-1001-0
Tolnafate 1 percent
Cream USP 1 percent Antifungal

Relieves Itching and Burning

Cures and Prevents Athlete's Foot

Prevents and Relieves Itching and Redness

Anti-Itch Cream for Skin Irritations

Compare to Tinactin (R) active ingredient
This product is n ot manufactured or distributed by Schering-Plough Healthcare Products, Inc. owner of the registered Trademark Tinactin

Maximum Strength

Net 1 oz(28.3g)

Exclusively distributed by:
Morales Distributors, Inc
Mayaguez, P.R. 00682

Made in Korea

INGREDIENTS AND APPEARANCE

TOLNAFTATE  
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53210-1001
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
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHLOROCRESOL (UNII: 36W53O7109)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53210-1001-0	1 in 1 BOX
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/25/2012

Labeler - Morales Distributors, Inc. (127151731)