TOLNAFTATE  - tolnaftate cream 
Morales Distributors, Inc.

Disclaimer: 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.

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Tolnaftate 1 percent

Active ingredient (in each gram)

Tolnaftate 1 percent

Purpose

Antifungal

Uses

Warnings

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:53210-1001
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 9/2012
Document Id: 8bc77776-7313-4c74-88b0-8122b1d7df33
Set id: 43520bea-a2f0-4805-8499-b5da1070e460
Version: 5
Effective Time: 20120928
 
Morales Distributors, Inc.