ATHLETES FOOT- tolnaftate spray

Athletes Foot by

Drug Labeling and Warnings

Athletes Foot by is a Otc medication manufactured, distributed, or labeled by Taizhou Ludao Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active IngredientPurpose

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

PURPOSE

Uses

• cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
• if used daily, can prevent recurrence of athlete's foot
• relieves symptoms of athlete's foot, including itching, burning and cracking

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age unless directed by a doctor.

INDICATIONS & USAGE

DG Health

Athlete's Foot Liquid Spray Tolnaftate 1% Antifungal

Compare to active ingredeint in Tinactin®*

Cures and prevents most athlete's foot

Relieves burning and itching

Net Wt 5.3oz (150g)

WARNINGS

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 temperatures above 120oF (49oC).

When using this product

• avoid contact with eyes and face
• 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
• there is no improvement after 4 weeks

DOSAGE & ADMINISTRATION

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 the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once a day
• use daily for 4 weeks; if condition persists longer, consult a doctor
• to prevent athlete's foot, apply once or twice daily (morning and night)
• this product is not effective on the scalp or nails

INACTIVE INGREDIENT

Inactive Ingredients

isobutane, alcohol denat. (29% w/w), propane, PPG-12-buteth-16, butylated hydroxytoluene

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ATHLETES FOOT 
tolnaftate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50942-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOBUTANE (UNII: BXR49TP611)
ALCOHOL (UNII: 3K9958V90M)
PROPANE (UNII: T75W9911L6)
PPG-12-BUTETH-16 (UNII: 58CG7042J1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50942-003-01	150 g in 1 BOTTLE; Type 0: Not a Combination Product	11/04/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	11/04/2014

Labeler - Taizhou Ludao Cosmetics Co., Ltd. (679885595)

Establishment
Name	Address	ID/FEI	Business Operations
Taizhou Ludao Cosmetics Co., Ltd.		679885595	manufacture(50942-003)