LEADER ANTIFUNGAL TOLNAFTATE- tolnaftate cream

LEADER ANTIFUNGAL TOLNAFTATE by

Drug Labeling and Warnings

LEADER ANTIFUNGAL TOLNAFTATE by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                     Purpose

Tolnaftate 1%.........................................................Antifungal

PURPOSE

Uses

• proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
• proven effective in the prevention of athlete's foot with daily use
• for effectively relief of itching, burning and cracking

WARNINGS

Warnings

For external use only

WHEN USING

When using this product avoid contact with the eyes.

STOP USE

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks

DO NOT USE

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• Wash affected area and dry thoroughly
• Apply a thin layer over affected area twice daily (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 week; if condition persists longer, ask a doctor
• this product is not effective on the scalp or nails

STORAGE AND HANDLING

Other Information

• store between 20 o to 25 oC (68 o to 77 oF)
• Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive Ingredients

butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, prolyoxyethylene cetyl ether, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

DOSAGE & ADMINISTRATION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Made in Korea

PRINCIPAL DISPLAY PANEL

DRUG: LEADER ANTIFUNGAL TOLNAFTATE

GENERIC: TOLNAFTATE

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-0794-0

PACKAGING: 28 g in 1 TUBE

ACTIVE INGREDIENT(S):

• TOLNAFTATE 10mg in 1g

INACTIVE INGREDIENT(S):

• BUTYLATED HYDROXYTOLUENE
• WATER
• PROPYLPARABEN
• SORBITAN MONOSTEARATE
• PROPYLENE GLYCOL
• CETYL ALCOHOL
• METHYLPARABEN
• PARAFFIN
• STEARYL ALCOHOL

INGREDIENTS AND APPEARANCE

LEADER ANTIFUNGAL TOLNAFTATE 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0794(NDC:37205-197)
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL ALCOHOL (UNII: 936JST6JCN)
PARAFFIN (UNII: I9O0E3H2ZE)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-0794-0	28 g in 1 TUBE; Type 0: Not a Combination Product	10/18/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/18/2017

Labeler - REMEDYREPACK INC. (829572556)