LAMISIL AF

Manufacturer: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Effective date: 2018-08-27
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:52:17

Label at a glance#

ProductLAMISIL AF DEFENSE

Active ingredientTOLNAFTATE

Label structure10 sections

Indications and 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

Dosage and administration

• 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...

Storage and handling

• store between 20 0 C to 25 0 C (68 0 F to 77 0 F) • see container bottom for lot number and expiration date • In case of clogging, remove button and clean nozzle with a pin

Contacts and useful links#

PhoneLabel contact1-800-452-0051

Websitewww.lamisil.com

www.lamisil.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

in children under 2 years of age unless directed by a doctor

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation occurs or gets worse
no improvement within 4 weeks

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

call 1-800-452-0051

Additional information listed on other panels

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-6114-46

TOLNAFTATE 1% - ANTIFUNGAL

LAMISIL^AF
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-6114-46	GM - Gram	0067-6114	94c04464-93d9-4d27-8377-1164773cb0e5	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	1
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	1
ALUMINUM STARCH OCTENYLSUCCINATE	INACTIVE INGREDIENT	I9PJ0O6294	1
ISOBUTANE	INACTIVE INGREDIENT	BXR49TP611	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	1
PROPANE	INACTIVE INGREDIENT	T75W9911L6	1
PROPYLENE CARBONATE	INACTIVE INGREDIENT	8D08K3S51E	1
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	1
STEARALKONIUM HECTORITE	INACTIVE INGREDIENT	OLX698AH5P	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

LAMISIL AF DEFENSE
Tolnaftate
ALUMINUM STARCH OCTENYLSUCCINATE
ISOPROPYL MYRISTATE
PROPYLENE CARBONATE
SORBITAN MONOOLEATE
STEARALKONIUM HECTORITE
TALC
ISOBUTANE
PROPANE
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0067-6114	0067-6114-46

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TOLNAFTATE	06KB629TKV	ACTIB
ALUMINUM STARCH OCTENYLSUCCINATE	I9PJ0O6294	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
PROPYLENE CARBONATE	8D08K3S51E	IACT
SORBITAN MONOOLEATE	06XEA2VD56	IACT
STEARALKONIUM HECTORITE	OLX698AH5P	IACT
TALC	7SEV7J4R1U	IACT
ISOBUTANE	BXR49TP611	IACT
PROPANE	T75W9911L6	IACT
ALCOHOL	3K9958V90M	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 77 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, FOAM / TOPICAL		144 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FOR SUSPENSION / ORAL		24 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, DELAYED RELEASE / ORAL		525 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	SOLUTION / ORAL		1080 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / TOPICAL		213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM, EXTENDED RELEASE / TRANSDERMAL	20.4 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TOPICAL		29 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ISOBUTANE	ISOBUTANE	BXR49TP611	AEROSOL / TOPICAL		4484 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / RECTAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	ELIXIR / ORAL	4.5 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	LOTION / TOPICAL		7 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	GEL / TOPICAL		20 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLENE CARBONATE	PROPYLENE CARBONATE	8D08K3S51E	OINTMENT / TOPICAL		3000 mg	Exact identifier — unii candidate
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	LOTION / TOPICAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / VAGINAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION / ORAL		234 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, SPRAY / TOPICAL	6.89 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TRANSDERMAL		113 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM / TRANSDERMAL	58.08 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TRANSDERMAL		85 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ISOBUTANE	ISOBUTANE	BXR49TP611	AEROSOL, FOAM / TOPICAL	18 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
ISOBUTANE	ISOBUTANE	BXR49TP611	AEROSOL, SPRAY / TOPICAL		4484 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, COATED / ORAL	0.13 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER / TOPICAL		9235 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	CREAM / TOPICAL		11000 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	EMULSION / TOPICAL		34050 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
ALUMINUM STARCH OCTENYLSUCCINATE	ALUMINUM STARCH OCTENYLSUCCINATE	I9PJ0O6294	CREAM / TOPICAL		321 mg	Exact identifier — unii candidate
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ISOBUTANE	ISOBUTANE	BXR49TP611	AEROSOL, FOAM / RECTAL		142 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	SPRAY / TOPICAL		8 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL / TOPICAL	9.3 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SORBITAN MONOOLEATE	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TOPICAL		7 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SUSPENSION / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / TOPICAL		65000 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OINTMENT / TOPICAL	35 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
27b9c3f2-4717-497f-994d-21096e3f3e15			36393a51-bca1-4c47-9ba0-94ceff5bd1ae	2018-08-27	Warnings	Exact identifier spl id: 27b9c3f2-4717-497f-994d-21096e3f3e15 spl set id: 36393a51-bca1-4c47-9ba0-94ceff5bd1ae

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.