Label: ZOHAR ANTI CAVITY MOUTHWASH COOLMINT FLAVOUR- sodium fluoride liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 27, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient

    Sodium fluoride 0.05% (0.02% w/v fluoride ion)

    Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities

  • Warnings

    Keep out of reach of children.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 6 years of age and older:
    • use once a day after brushing your teeth with a toothpaste 
    • vigorously swish 10 ml (2teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
    • do not swallow the rinse 
    • do not eat or drink for 30 minutes after rinsing
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • supervise children as necessary untill capable of using without supervision.
    • Children under 6 years of age:consult a dentist or doctor.
  • Inactive ingredients

    Water, Xylitol, Glycerin, Sodium Benzoate, Flavor, Sodium Citrate, Sodium Saccharin, Citric Acid, Poloxamer 407, FD&C Blue #1.

  • Label

    Front Label.jpgBack Label.jpg

  • INGREDIENTS AND APPEARANCE
    ZOHAR ANTI CAVITY MOUTHWASH COOLMINT FLAVOUR 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84045-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84045-001-00500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/15/2024
    Labeler - ZOHAR KOSHER LIMITED (221033261)
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

More Info on this Drug

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