LEADER MEDICATED- tolnaftate aerosol, powder

Leader Medicated by

Drug Labeling and Warnings

Leader Medicated by is a Otc medication manufactured, distributed, or labeled by Cardinal Health Inc., Premier Brands of America, American Spray Tech LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

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

Uses

Uses

• cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
• if used daily, can prvent recurrance of athlete's foot
• relieves symptoms of athlete's foot, including itching, burning and cracking

Warnings

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 120 o F

When using this product

• do not get into eyes or mouth
• use only as directed; intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal

​Stop use and ask a doctor if

• irritation occurs
• no improvement after four weeks for athlete's foot,

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 toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch, if condition persists, consult a doctor
• to prevent athlete's foot, apply daily (morning and night)
• this product is not effective on scalp or nails
• in case of clogging, clear nozzle under running water

Other infomation

Store between 20 o and 30 o C (68 o and 86 o F)

Inactive ingredients

SD alcohol 40-B (14% w/w), BHT, Isobutane (propellant), PPG-12-buteth-16, talc

Questions

Call 1-866-964-0939

Principal Display Panel

LEADER

Antifungal Powder Spray

Medicated

Tolnaftate 1%

Cures Most Symptoms of Jock Itch
Relieves Itching, Chafing and Burning

NET WT 4.6 OZ (130 g)

INGREDIENTS AND APPEARANCE

LEADER MEDICATED 
tolnaftate aerosol, powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-344
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)	0.14 g  in 1 g
ISOBUTANE (UNII: BXR49TP611)
PPG-12-BUTETH-16 (UNII: 58CG7042J1)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-344-66	130 g in 1 CAN; Type 0: Not a Combination Product	03/15/2008	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/15/2008	07/31/2020

Labeler - Cardinal Health Inc. (097537435)