TINACTIN- tolnaftate aerosol, powder

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

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Active ingredient:
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)
Available from:
Bayer HealthCare LLC.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antifungal - proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) - helps prevent most athlete's foot with daily use - for effective relief of itching, burning and cracking
Authorization status:
OTC monograph final
Authorization number:
11523-0777-2

TINACTIN- tolnaftate aerosol, powder

Bayer HealthCare 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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Tinactin

Drug Facts

Active ingredient

Tolnaftate 1%

Purpos e

Antifungal

Us es

proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea

corporis)

helps prevent most athlete's foot with daily use

for effective relief of itching, burning and cracking

Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame

When using this product

avoid contact with the eyes

use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be

harmful or fatal.

contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Stop use and ask a doctor if

irritation occurs

there is no improvement within 4 weeks

Do not use on children under 2 years of age unless directed by a doctor.

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

away.

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 daily

use daily for 4 weeks; if condition persists longer, ask a doctor

®

to prevent athlete's foot, apply once or twice daily (morning and/or night)

this product is not effective on the scalp or nails

in case of clogging, clean nozzle with pin

Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

alcohol denat. (11% v/v), butylated hydroxytoluene, isobutane, PPG-12-buteth-16, talc

Ques tions ?

1-866-360-3266

PRINCIPAL DISPLAY PANEL - 133g Can Label

TOUGH ACTIN'

Tinactin

tolnaftate ANTIFUNGAL

Cures and prevents

most athlete's foot

Relieves itching

& burning

DEODERANT

POWDER SPRAY

fights odor all day

NET WT 133g (4.6 oz)

TINACTIN

tolnaftate aerosol, powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11523-0 777

Route of Administration

TOPICAL

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 g

Inactive Ingredients

Bayer HealthCare LLC.

Ingredient Name

Stre ng th

ISO BUTANE (UNII: BXR49 TP6 11)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

PPG-12 -BUTETH-16 (UNII: 58 CG70 42J1)

TALC (UNII: 7SEV7J4R1U)

Product Characteristics

Color

white (White to o ff-white)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:11523-0 777-2

133 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

0 9 /23/19 9 3

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

0 9 /23/19 9 3

Labeler -

Bayer HealthCare LLC. (112117283)

Revised: 6/2020

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