LUCKY SUPER SOFT ANTIFUNGAL FOR ATHLETES FOOT- tolnaftate powder 
Blue Sea Aerosol & Daily Care Co.,Ltd

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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Antifungal Powder Spray

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

Package Label

LUCKY SUPER SOFT ANTIFUNGAL  FOR ATHLETES FOOT
tolnaftate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72119-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
BUTANE (UNII: 6LV4FOR43R)  
PROPANE (UNII: T75W9911L6)  
TROLAMINE (UNII: 9O3K93S3TK)  
STARCH, CORN (UNII: O8232NY3SJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72119-001-8585 g in 1 CAN; Type 0: Not a Combination Product02/19/2018
2NDC:72119-001-5757 g in 1 CAN; Type 0: Not a Combination Product04/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/19/2018
Labeler - Blue Sea Aerosol & Daily Care Co.,Ltd (544373091)

Revised: 2/2020
Document Id: 9f69adbe-45c9-2bad-e053-2995a90a1cea
Set id: 9f69c16d-81c3-93e0-e053-2a95a90a4bc4
Version: 1
Effective Time: 20200225
 
Blue Sea Aerosol & Daily Care Co.,Ltd