Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

LAMISL AF DEFENSE- tolnaftate cream 
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

Purpose

Antifungal

Uses

• treats and prevents most athlete’s foot (tinea pedis), and ringworm (tinea corporis)
• prevents most athlete’s foot (tinea pedis) with daily use
• relieves itching, burning, cracking and scaling which accompany these conditions

Warnings

For external use only

Do not use

• on children under 2 years of age unless directed by a doctor
• in or near the mouth or the eyes
• on nails or scalp 

When using this product

do not get into eyes. If eye contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• irritation occurs or gets worse
• no improvement in athlete’s foot 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 of age and over
  • to open tube, peel off foil seal
  • wash the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
  • for athlete’s foot pay special attention to spaces between the toes
    • wear well-fitting, ventilated shoes
    • change shoes and socks at least once daily
  • use daily for 4 weeks; if condition persists longer, consult a doctor
  • to prevent athlete’s foot, apply once or twice daily (morning and/or night)
  • supervise children in the use of this product
  • wash hands after each use
• children under 2 years of age: as a doctor

Other information

• do not use if seal on tube is broken or is not visible
• store at controlled room temperature 200C- 250C (680F- 770F)

Inactive ingredients

acrylates/C10-30 acrylate cross polymer, carbomer, corn starch, cyclomethicone, edetate disodium, ethyl alcohol, fragrance, isopropyl mysristate, propylene glycol, purified water, strong ammonia solution

Questions or comments?

call 1-800-452-0051

 

 Distr. By: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©2008

Principal Display

LAMISL AF  DEFENSE
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-6266
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
CYCLOMETHICONE (UNII: NMQ347994Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STARCH, CORN (UNII: O8232NY3SJ)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-6266-30	1 in 1 CARTON	01/01/2010	03/31/2015
1		30 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2010	03/31/2015

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 7/2019

Document Id: 1fc41b26-abd7-4722-b3bd-f65152387f17

34390-5

Set id: c0ad1ce5-bdb3-43cc-8d07-84f250eb289f

Version: 2

Effective Time: 20190730

 

GlaxoSmithKli