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Tolnaftate

Morales Distributors, Inc.

Tolnaftate 1 percent


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each gram)

Tolnaftate 1 percent

Purpose

Antifungal

Tolnaftate 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

Tolnaftate 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

Tolnaftate
Tolnaftate
Tolnaftate

Tolnaftate

TOLNAFTATE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53210-1001
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Tolnaftate TOLNAFTATE 1 g

Inactive Ingredients

Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C
CETYL ALCOHOL
chlorocresol
GLYCERIN
GLYCERYL MONOSTEARATE
LIGHT MINERAL OIL
water
STEARIC ACID

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2012-09-25


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