LUCKY SUPER SOFT ANTIFUNGAL FOR ATHLETES FOOT- tolnaftate powder

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

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Active ingredient:
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)
Available from:
Delta Brands, Inc
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 on children under 2 years of age unless directed by a doctor ■ irritation occurs ■ there is no improvement within 4 weeks
Authorization status:
OTC monograph final
Authorization number:
20276-108-57, 20276-108-85

LUCKY SUPER SOFT ANTIFUNGAL FOR ATHLETES FOOT- tolnaftate powder

Delta Brands, Inc

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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Drug Facts

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

LUCKY SUPER SOFT ANTIFUNGAL FOR ATHLETES FOOT

tolnaftate powder

Delta Brands, Inc

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:20 276 -10 8

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

1 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

BUTANE (UNII: 6 LV4FOR43R)

PRO PANE (UNII: T75W9 9 11L6 )

TRO LAMINE (UNII: 9 O3K9 3S3TK)

STARCH, CO RN (UNII: O8 232NY3SJ)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:20 276 -10 8 -8 5

8 5 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

0 2/19 /20 18

2

NDC:20 276 -10 8 -57

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

0 4/12/20 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

0 2/19 /20 18

Labeler -

Delta Brands, Inc (102672008)

Revised: 4/2019

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