ANTI-FUNGAL- tolnaftate powder 
Rij Pharmaceutical Corporation

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.

----------

Anti-Fungal Powder

Active Ingredient

Tolnaftate 1 %

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use on children under 2 years of age.

When using this product avoid contact with the eyes

Stop use and ask a doctor if 

Keep out of reach of children.


If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For athletes foot

For jock itch

Other information

store between 2° - 30° C (36° - 86° F)

Inactive ingredients

starch, talc

Package Label Display

Anti-Fungal Powder Label

ANTI-FUNGAL 
tolnaftate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE.45 g  in 45 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53807-123-4545 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/16/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/16/1999
Labeler - Rij Pharmaceutical Corporation (144679156)
Establishment
NameAddressID/FEIBusiness Operations
Rij Pharmaceutical Corporation144679156manufacture(53807-123)

Revised: 4/2018
Document Id: cc3a9076-c345-4086-97af-926b9af80d06
Set id: eb7eba3b-182d-4be9-971c-fde428b9eb5f
Version: 2
Effective Time: 20180430
 
Rij Pharmaceutical Corporation