FOOT WORKS HEALTHY ANTIFUNGAL- tolnaftate spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)
Available from:
New Avon LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses • proven clinically effective in the treatment of most athlete’s foot (tinea pedis) • relieves itching, burning feet • prevents the recurrence of most athlete’s foot (tinea pedis) with daily use
Authorization status:
OTC monograph final
Authorization number:
10096-0272-1

FOOT WORKS HEALTHY ANTIFUNGAL- tolnaftate spray

New Avon 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.

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Footworks Antifungal Spray

Active ingredient

Tolnaftate 1.0%.........................

Purpose

.......................Antifung al

Uses

proven clinically effective in the treatment of most athlete’s foot (tinea pedis)

relieves itching, burning feet

prevents the recurrence of most athlete’s foot (tinea pedis) with daily use

Directions

To treat athlete’s foot, clean the affected area with soap and water and dry thoroughly. Apply a thin

layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Use

daily for 4 weeks. If condition persists longer, consult a doctor. Not effective for infections of the

nails or scalp.

To prevent athlete’s foot, clean the feet and dry thoroughly. Apply a thin layer of the product to the

feet once or twice daily (morning and/or night).

Supervise children in the use of this product.

Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, cotton socks, and

change shoes and socks at least once daily.

Inactive ingredients

SD ALCOHOL 40-B, PEG-12, PEG-6, PROPYLENE CARBONATE, PARFUM/FRAGRANCE, BHT.

QUESTIONS? Call 1-800-FOR-AVON or 1-800-265-AVON in Canada

Warnings

For external use only

Do not use

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

When using this product

avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

irritation occurs or if there is no improvement within 4 weeks

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

away.

Flammable. Keep from fire or heat.

FOOT WORKS HEALTHY ANTIFUNGAL

tolnaftate spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 0 9 6 -0 272

Route of Administration

TOPICAL

New Avon LLC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TO LNAFTATE (UNII: 0 6 KB6 29 TKV) (TOLNAFTATE - UNII:0 6 KB6 29 TKV)

TOLNAFTATE

10 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:10 0 9 6 -0 272-

10 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333C

12/19 /20 11

Labeler -

New Avon LLC (080143520)

Revised: 1/2019

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