Your browser does not support JavaScript! TOLNAFTATE CREAM [MORALES DISTRIBUTORS, INC.]
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RxNorm Names

TOLNAFTATE cream
[Morales Distributors, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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

box label

box label

tube label

TOLNAFTATE  
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53210-1001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C 
CETYL ALCOHOL 
CHLOROCRESOL 
GLYCERIN 
GLYCERYL MONOSTEARATE 
LIGHT MINERAL OIL 
WATER 
STEARIC ACID 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53210-1001-01 in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/25/2012
Labeler - Morales Distributors, Inc. (127151731)

Revised: 9/2012
 
Morales Distributors, Inc.

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