Label: XTRACARE ANTIFUNGAL FOOT- tolnaftate 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 September 13, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient  ............................................ Purpose

    Tolnaftate 1% .................................................. Antifungal

  • PURPOSE

    Use

    • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • if used daily, can prevent recurrence of athlete's foot
    • relieves symptoms of athlete's foot, including itching, burning and cracking
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age unless directed by a doctor.

  • INDICATIONS & USAGE

    XtraCare® Antifungal Foot Spray

    For Athlete's Foot

    Tolnaftate 1%

    • Relieves Itching & Burning
    • Cures & Prevents Most Athlete's Foot
    • Fights Odor All Day

    *Compare to the Active Ingredient in Tinactin®

    CAUTION  Contents under pressure - Read precautions on back panel.

    Net Wt 3.5 Oz (100g)

  • WARNINGS

    Warnings

    For external use only.

    Flammable. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120oF (49oC).

    When using this product

    • avoid eyes & face
    • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement after 4 weeks
  • DOSAGE & ADMINISTRATION

    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 betwen the toes; wear well-fitted, ventilated shoes and change shoes and socks at least once a day.
    • use daily for 4 weeks; if condition persists longer, consult a doctor
    • to prevent athlete's foot, apply once or twice daily (morning and night)
    • in case of clogging, clean nozzle with a pin
  • INACTIVE INGREDIENT

    Inactive Ingredients

    butane, propane, alcohol, butylated hydroxytoluene, talc.

  • OTHER SAFETY INFORMATION

    Other information store between 68o to 77oF (20o to 25oC)

    Questions/Comments? 1-855-345-5575

    *This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Tinactin®

    DISTRIBUTED BY

    REJOICE INTERNATIONAL, INC

    NORTHVILLE, MI 48168 USA

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    XTRACARE ANTIFUNGAL FOOT 
    tolnaftate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-056
    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
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-056-01100 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/11/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/11/2014
    Labeler - Rejoice International (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ludao Cosmetics Co., Ltd.679885595manufacture(57337-056)