FIRST AID ANTIFUNGAL MEDICATED CREAM 0.5 OZ- tolnaftate cream 
First Aid Reserach Corp

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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Active ingredient                                                                                                                        Purpose

Tolnaftate 1%-----------------------------------------------------------------------------------------------Antifungal

Uses

Proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

Helps preent most athlete's foot with daily use

for effective relief of 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

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 immediately.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

store between 20° to 25° (68° to 77°F)

Lot No. & Exp. Date;see box or see crimp of tube

ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, monobasic sodium phosphate dihydrate, propylene glycol, purified water, white petrolatum

Distributed by:

First Aid Research Corp.

Wantagh, NY U.S. A. 11793

Made in Korea

image description

FIRST AID ANTIFUNGAL MEDICATED CREAM 0.5 OZ 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75983-515
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROCRESOL (UNII: 36W53O7109)  
PARAFFIN (UNII: I9O0E3H2ZE)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75983-515-141 in 1 CARTON
114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/09/2014
Labeler - First Aid Reserach Corp (089405927)

Revised: 10/2014
Document Id: 1b89ee06-bee4-4eff-a7ce-19895a877bb6
Set id: d7b8a217-0875-4473-940e-859f6d09c850
Version: 1
Effective Time: 20141009
 
First Aid Reserach Corp