Label: ANTISEPTIC SINOFRESH KOOL BLAST THROAT- mentha piperita spray

  • NDC Code(s): 59228-105-11
  • Packager: EMS Contract Packaging
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 22, 2022

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  • ACTIVE INGREDIENTS

    MENTHA PIPERITA 3X

  • PURPOSE

    ORAL ANTISEPTIC

  • USES

    • KILLS GERMS AND BACTERIA
    • REDUCES GERMS AND BACTERIA IN THE MOUTH AND THROAT

  • WARNINGS

    ASK A DOCTOR BEFORE USE IF YOU HAVE:

    • HAD ANY MEDICAL PROCEDURES FOR THE MOUTH OR THROAT
    • RAW, SCRATCHY, OR IRRITATED THROAT

    wHEN USING THIS PRODUCT:

    • DO NOT SPRAY IN EYES. IF CONTACT OCCURS, RINSE WITH WATER
    • DO NOT SHARE DISPENSER WITH OTHERS

    STOP USE AND ASK DOCTOR:

    • IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR WORSENS
    • A RASH OR IRRITATION OCCURS
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    IF MORE THAN IS USED FOR SPRAYING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY, 800-222-1222

  • DIRECTIONS

    • ADULTS AND CHILDREN 12 YEARS AND OLDER, 3 TO 4 SPRAYS IN THE THROAT, THREE TIMES A DAY, OR AS NEEDED
    • CHILDREN UNDER 12 YEARS ASK A DOCTOR

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE, AWAY FROM DIRECT SUNLIGHT

  • INACTIVE INGREDIENTS

    AQUA (WATER), BENZALKONIUM CHLORIDE, CETYLPYRIDINIUM CHLORIDE, EDETATE DISODIUM, EUCALYPTUS OIL, GLYCERIN, MENTHOL, POLYSORBATE 80, SORBITOL, SUCRALOSE, XYLITOL

  • QUESTIONS?

    888-460-4774

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Sinofresh Kool Blast_FR

    01b LBL_Sinofresh Kool Blast_BK

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SINOFRESH KOOL BLAST THROAT 
    mentha piperita spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59228-105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA3 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59228-105-1159.1 mL in 1 BOTTLE; Type 0: Not a Combination Product09/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/28/2020
    Labeler - EMS Contract Packaging (048602791)
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