TOLNAFTATE - tolnaftate cream 
NeoPharm Co., Ltd.

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.

----------

Drug Facts

Purpose

Antifungal

Uses

Warning

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

Other Information

Inactive ingredients

Carbomer, Cetyl alcohol, Cholesterol, Dibasic sodium phosphate hydrate, Glycerin, Glyceryl monostearate, Light liquid paraffin, Myristoyl/palmitoyl oxostearamide/arachamide MEA, PEG-15 glyceryl stearate, Stearic acid, Water

Principal Display Panel

Tolnaftateimage of carton label

Active Ingredients

Tolnaftate 1%

TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0057
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Glycerin (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Paraffin (UNII: I9O0E3H2ZE)  
Stearic acid (UNII: 4ELV7Z65AP)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-0057-11 in 1 BOX
128 g in 1 TUBE
2NDC:51141-0057-61 in 1 BOX
220 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/27/2010
Labeler - NeoPharm Co., Ltd. (631101883)
Registrant - NeoPharm Co., Ltd. (631101883)
Establishment
NameAddressID/FEIBusiness Operations
NeoPharm Co., Ltd.631101883manufacture

Revised: 8/2010
Document Id: 0976b365-d5b5-4396-a17e-b8a1c32616e4
Set id: 5fc47184-82ae-4a0a-8f66-dfa03b1c5883
Version: 1
Effective Time: 20100827
 
NeoPharm Co., Ltd.