Personal Care Antifungal

Dosage form: spray
Ingredients: TOLNAFTATE 1g in 100g
Labeler: Personal Care Products, Inc.
NDC Code: 29500-0035

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.

Personal Care Antifungal Powder Spray For Athlete's Foot Tolnaftate 1%

Drug Facts

Active Ingredient                                    Purpose

Tolnaftate 1%..........................................Antifungal

Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)

if used daily, can prevent recurrence of athlete's foot

relieves symptoms of athlete's foot, including itching, burning and cracking

For external use only.

Flammable. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. D not store at temperatures above 120 degrees F (45 degrees C)


When using this product

avoid contact eyes and face

use only as directed

intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.


Stop use and ask a doctor if

irritation occurs

there is no improvement after 4 weeks.

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

Directions

Wash affected area and dry thoroughly

shake can well and spray a thin layer over affected area twice daily (morning and night)

supervise children in the use of this product

for athlete's foot: pay special attention to spaces between the toes, wear well fitting, ventilated shoes and change shoes and socks at least once a day.

use daily for 4 weeks; if condition persists longer, consult a doctor

to prevent athlete's foot, apply once or twice daily (morning and night)

in case of clogging, clean nozzle with a pin.

Other Information: store between 68 degrees to 77 degrees f (20 degrees to 25 degrees C)

Inactive Ingredients: alcohol, isobutane, perfume, propane, n-butane, talc powder

*This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Tinactin (r)



Distributed by

Personal Care Products,  Inc.

Bingham Farms, MI 48025-3463

Made In China

Personal Care

Antifungal

Powder Spray

For Athlete's Foot

Tolnaftate 1%

*Compare to the Active Ingredient in Tinactin

Cures and Prevents Most Athlete's Foot

Relieves Itching and burning

Net Wt. 3.5 oz (100g)

PERSONAL CARE ANTIFUNGAL 
tolnaftate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-0035
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ISOBUTANE 
PROPANE 
BUTANE 
TALC 
Packaging
#Item CodePackage Description
1NDC:29500-0035-3100 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33305/21/2010
Labeler - Personal Care Products, Inc. (603124298)
Establishment
NameAddressID/FEIOperations
Taizhou Ludao Cosmetics Co., Ltd.679885595manufacture

Revised: 05/2010
 
Personal Care Products, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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