LUCKY SUPER SOFT ANTIFUNGAL FOR ATHLETES FOOT- tolnaftate powder

LUCKY SUPER SOFT ANTIFUNGAL by

Drug Labeling and Warnings

LUCKY SUPER SOFT ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Blue Sea Aerosol & Daily Care Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

■ 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

Do not use

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

When using this product

■ avoid contact with eyes ■ use only as directed. Intentional misuse by deliberetely concentrating and inhaling contents can be harmful or fatal ■ contents under pressure. Do not puncture or incinerate.

Do not stire at a temperature above 120ºF (49ºC​)

Stop use and ask a doctor if

■ irritation occurs ■ 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

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 conditions persist 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 68º to 77ºF (20º to 25ºC)

Inactive ingredients

alcohol denat., butane, fragrance, propane, triethanolamine, zea mays (corn) starch

Package Label

INGREDIENTS AND APPEARANCE

LUCKY SUPER SOFT ANTIFUNGAL  FOR ATHLETES FOOT
tolnaftate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72119-001
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
ALCOHOL (UNII: 3K9958V90M)
BUTANE (UNII: 6LV4FOR43R)
PROPANE (UNII: T75W9911L6)
TROLAMINE (UNII: 9O3K93S3TK)
STARCH, CORN (UNII: O8232NY3SJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72119-001-85	85 g in 1 CAN; Type 0: Not a Combination Product	02/19/2018
2	NDC: 72119-001-57	57 g in 1 CAN; Type 0: Not a Combination Product	04/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	02/19/2018

Labeler - Blue Sea Aerosol & Daily Care Co.,Ltd (544373091)