Label: LUXURY- athlete foot powder aerosol, spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 10, 2021

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  • 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 prevents most athlete's foot with daily use
    • for effective relief of itching, cracking and burning
  • 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

    • shake can well and spray a thin layer over affected area twice daily (morning and night)
    • wash affected area and dry thoroughly
    • hold can 4-6 inches away from affected area
    • 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
    • if condition persists longer, consult a doctor
    • this product is not effective on the scalp or nails
    • in case of  clogging , clean nozzle with a pin
  • Other information

    • store between 20° and 25°C (68° and 77°F)
  • Inactive ingredients

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

  • Principal Display Panel

    1

  • INGREDIENTS AND APPEARANCE
    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)
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