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LAMISL AF DEFENSE by Novartis Consumer Health, Inc.

Medically reviewed on January 1, 2018

Dosage form: aerosol, spray
Ingredients: TOLNAFTATE 10mg in 1g
Labeler: Novartis Consumer Health, Inc.
NDC Code: 0067-6114

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.

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses
  • Proven clinically effective in the treatment of most athlete’s foot (tinea pedis), and ringworm (tinea corporis)
  • Clinically proven to prevent most athlete’s foot with daily use
  • For effective relief of itching, burning and cracking

Warnings

For external use only

Flammability Warning: Contents under pressure. Do not puncture or incinerate. Flammable mixture; do not use near fire or flame, or expose to heat or temperature above 490C (1200F). Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Do not use
  • in children under 2 years of age unless directed by a doctor

When using this product
  • avoid contact with the eyes.

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

Keep out of reach of children.

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

Directions
  • adults and children 2 years and older
    • wash the affected area and dry thoroughly
    • Shake can well: hold 4” to 6” from skin
    • spray a thin layer over affected area twice a day (morning and night) or as directed by a doctor
    • 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 condition persists longer, ask a doctor
    • to prevent athlete’s foot, apply once or twice daily (morning and/or night).
    • this product is not effective on the scalp or nails.

Other information
  • store between 200C to 250C (680F to 770F)
  • see container bottom for lot number and expiration date
  • in case of clogging, remove button and clean nozzle with a pin

Inactive ingredients

aluminum starch octenyl succinate, fragrance, isopropyl myristate, propylene carbonate, SD alcohol 40-B (11%w/w), sorbitan oleate, stearalkonium hectorite, talc

Propellant: isobutane, propane

Questions or comments?

call 1-800-452-0051

Additional information listed on other panels

Distributed by:
Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622
©20XX

www.lamisilat.com

Principal Display

NDC 0067-6114-46

Lamisil AF
Defense®
Tolnaftate 1%, Antifungal

Spray Powder

PREVENTS MOST ATHLETE’S FOOT

ABSORBS WETNESS
CURES MOST ATHLETE’S FOOT

Net Wt. 4.6 oz (133 g)

LAMISL AF  DEFENSE
tolnaftate aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6114
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM STARCH OCTENYLSUCCINATE 
ISOPROPYL MYRISTATE 
PROPYLENE CARBONATE 
SORBITAN MONOOLEATE 
STEARALKONIUM HECTORITE 
TALC 
ISOBUTANE 
PROPANE 
Packaging
#Item CodePackage Description
1NDC:0067-6114-46133 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/01/2006
Labeler - Novartis Consumer Health, Inc. (879821635)

 
Novartis Consumer Health, Inc.

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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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