LAMISIL AF by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC Drug Facts

LAMISIL AF by

Drug Labeling and Warnings

LAMISIL AF by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LAMISIL AF DEFENSE- tolnaftate aerosol, spray 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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 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?

call 1-800-452-0051

Additional information listed on other panels

Distributed by:
GSK Consumer Healthcare,Warren, NJ 07059GSK Consumer Healthcare, Warren, NJ 0705
©2016 GSK group of companies or its licensor. All rights reserved.

www.lamisil.com

10002

DOT-2P

M5735

Principal Display

NDC: 0067-6114-46

TOLNAFTATE 1% - ANTIFUNGAL

LAMISILAF
DEFENSE®

SPRAY POWDER

PREVENTS MOST ATHLETE’S FOOT

ABSORBS WETNESS
CURES MOST ATHLETE’S FOOT

NET WT. 4.6 oz (133 g)

10002_Lamisil AF Defense Spray Powder_4.6 oz.JPG
LAMISIL AF  DEFENSE
tolnaftate aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0067-6114
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
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
TALC (UNII: 7SEV7J4R1U)  
ISOBUTANE (UNII: BXR49TP611)  
PROPANE (UNII: T75W9911L6)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0067-6114-46133 g in 1 CAN; Type 0: Not a Combination Product02/01/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/01/200603/31/2020
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 8/2018
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC