PERSONAL CARE ANTIFUNGAL  - tolnaftate spray 
Personal Care Products, 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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Drug Facts Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Keep out of reach of children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age unless directed by a doctor.

Uses

Warnings

For external use only

Flammable. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure Do not store in temperature above 120°F (49°C).

When using this product

Stop use and ask a doctor if

Directions

Other information

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

Inactive ingredients

alcohol, isobutane, perfume, propane, n-butane, talc powder.

ANTI FUNGAL POWDER SPRAY Label

PERSONAL CARE®

ANTIFUNGAL POWDER SPRAY
For Athlete's Foot

TOLNAFTATE 1%

*Compare to the Active Ingredients in Tinactin®

Cures and Prevents Most Athlete's Foot

Relieves Itching and Burning

*This product is not manufactured ir distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Tinactin®

Distributed by: Personal Care Products, Inc. Bingham Farms, MI 48025-3463

Made in China

footsprayPDP Label


PERSONAL CARE ANTIFUNGAL  
tolnaftate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-0035
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)  
ISOBUTANE (UNII: BXR49TP611)  
PROPANE (UNII: T75W9911L6)  
BUTANE (UNII: 6LV4FOR43R)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29500-0035-3100 g in 1 CANISTER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/21/2010
Labeler - Personal Care Products, Inc. (966155082)

Revised: 9/2015
Document Id: 07dd9f08-1f2c-4c9f-81b7-644a479c4a83
Set id: c01e1ec7-045b-4a32-abb5-9f624468ade7
Version: 5
Effective Time: 20150901
 
Personal Care Products, Inc.