LUXURY- athlete foot powder aerosol, spray 
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI

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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LUXURY Athlete's Foot Powder Spray

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only.

Extremely 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 temperature above 120 F (49 C)

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

Other information

Inactive ingredients

Alcohol denat, Butane , Isobutene , Triethanolamine , zea mays (corn) starch.

Principal Display Panel

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LUXURY 
athlete foot powder aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76772-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1.3 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
BUTANE (UNII: 6LV4FOR43R)  
ISOBUTYLENE (UNII: QA2LMR467H)  
TROLAMINE (UNII: 9O3K93S3TK)  
STARCH, CORN (UNII: O8232NY3SJ)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76772-022-5757 g in 1 CANISTER; Type 0: Not a Combination Product03/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/10/2021
Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
Establishment
NameAddressID/FEIBusiness Operations
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI533120570manufacture(76772-022)

Revised: 3/2021
Document Id: bd3aecf5-3806-53d6-e053-2a95a90a83db
Set id: 61ded99e-970e-4c61-8b61-1cac61e309da
Version: 2
Effective Time: 20210310
 
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI