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Tolnafate by Topco Associates LLC

Medically reviewed on Dec 4, 2017

Dosage form: aerosol, spray
Ingredients: TOLNAFTATE 1.3g in 130g
Labeler: Topco Associates LLC
NDC Code: 36800-876

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.

Topcare Tolnaftate Powder Spray

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses
  • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • if used daily, can prevent recurrence of athlete's foot
  • relieves sypmtoms 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. Do not store at temperature above 120ºF

When using this product
  • do not get into eyes or mouth, if products get into eyes, rinse eyes thoroughly with water
  • use only as directed

Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

Stop use and ask a doctor if
  • irritation occurs
  • no improvement within 4 weeks

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. 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 daily
  • use daily for 4 weeks; if conditions persist, consult a doctorto prevent athlete's foot, apply once or twice daily (morning and/or night)in case of clogging, clear nozzle under running water

Other information

store between 20º and 30ºC (68ºF and 86º)

Inactive ingredients

BHT, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B, Zea Mays (Corn) Starch

Questions?

call 1-866-964-0939

Principal Display Panel

TopCare

Antifungal Powder Spray

Tolnaftate 1%

  • Cures most athlete's foot and prevents recurrances
  • Relieves itching, cracking & burning
  • Talc Free

NET WT 4.6 OZ (130g)

TOLNAFATE 
tolnaftate powder spray aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-876
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1.3 g  in 130 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
ISOBUTANE 
KAOLIN 
PPG-12-BUTETH-16 
ALCOHOL 
ZEA MAYS SUBSP. MAYS WHOLE 
Packaging
#Item CodePackage Description
1NDC:36800-876-46130 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/22/2017
Labeler - Topco Associates LLC (006935977)
Registrant - Premier Brands of America Inc. (063849780)
Establishment
NameAddressID/FEIOperations
Premier Brands of America Inc.080051232relabel(36800-876), repack(36800-876)
Establishment
NameAddressID/FEIOperations
American Spraytech L.L.C137135237manufacture(36800-876)

 
Topco Associates LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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