Label: SINOFRESH KOOLBLAST- sinofresh koolblast oral spray spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated October 12, 2020

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

View All Sections
  • Active Ingredients

    Mentha Piperita 3X

  • Purpose

    Oral Antiseptic

    Uses
    • Kills germs and bacteria
    • Reduces germs and bacteria in the mouth and throat

  • Warnings

    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 eyes
    with water
    • do not share dispenser with others

  • Stop Use

    Stop use and ask doctor if:
    • condition persists for more than 7 days or worsens
    • a rash or irritation occurs

  • Keep Our of Reach of Children

    Keep out of reach of children.
    If more than used for spraying is accidentally swallowed,
    get medical help or contact a Poison Control Center
    right away, 800-222-1222

  • Dosage and Administration

    Directions
    • Adults and children 12 years of age and older, 3 to 4
    sprays in the throat, three times a day, or as needed
    • Children under 12 years ask a doctor

  • Indications and Usage

    Oral Antiseptic

    • Reduces germs and bacteria in the mouth and throat

  • Inactive Ingredients

    Inactive Ingredients: Aqua (water), benzalkonium chloride, cetylpyridinium chloride, edetate disodium, eucalyptus oil, glycerin,
    menthol, polysorbate 80, sorbitol, sucralose, xylitol

  • Warnings

    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 eyes
    with water
    • do not share dispenser with others
    Stop use and ask doctor if:
    • condition persists for more than 7 days or worsens
    • a rash or irritation occurs

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    SINOFRESH KOOLBLAST 
    sinofresh koolblast oral spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79961-003
    Route of AdministrationOROPHARYNGEAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MENTHOL (UNII: L7T10EIP3A)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79961-003-0160 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/12/2020
    Labeler - ZapVir Inc. (117600850)
    Registrant - ZapVir Inc. (117600850)
    Establishment
    NameAddressID/FEIBusiness Operations
    EMS Acquisition Corp048602791manufacture(79961-003)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!