ZOHAR FINEST ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [BROOM LANE ENTERPRISES]

ZOHAR FINEST ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [BROOM LANE ENTERPRISES]
PDF | XML

NDC 55754-000-00
Set ID 1a57bfa0-3b18-4612-ad8c-5e651abb3530
Category HUMAN OTC DRUG LABEL
Packager Broom Lane Enterprises
Generic Name
Product Class
Product Number
Application Number PART355
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.05%

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental decay

  • WARNINGS

    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 milliliters 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 until capable of using without supervision.
    • Children under 6 years of age: Consult a dentist or doctor.
  • Inactive ingredients

    WATER, SORBITOL, GLYCERIN, POLOXAMER-407,
    SODIUM BENZOATE, SODIUM SACCHARIN,
    FLAVOR, SODIUM CITRATE, CITRIC ACID,
    CETYLPYRIDINIUM CHLORIDE, FD&C BLUE 1

  • Package Label

    Zohar finest
    Anticavity
    Mouthwash

    Sodium Fluoride 0.05%
    Rinses and Refreshes
    Anticavity

    25.3 fl oz (1.58 pt) (750 ml)

    IMPORTANT: Read directions for proper use.

    • Family Friendly
    • 6 Years - Adult
    • Alcohol-Free
    • Strengthens and
      Protects Teeth
    • Unique “feel fresh”
      formula
    • Aids in prevention
      of dental decay

    COOLMINT
    Flavor

    KOSHER
    FOR PASSOVER

    IMPORTANT: Read directions for proper use.

    25.3 fl oz (1.58 pt) (750 ml)

    www.zoharkosher.co.uk

    Do not use if seal on cap is broken.


    Did you know you can do more than
    just keep your family’s teeth clean?
    Zohar Mouthwash is a refreshing,
    great tasting, alcohol free mouthwash
    that is suitable for the whole
    family, from age 6 years to adult.
    It not only freshens, but contains
    active strengthening mineral which
    binds to the tooth enamel, to
    protect in areas that need it most.


    MANUFACTURED FOR:
    BROOM LANE ENTERPRISES, LTD
    QUALITY HOUSE, 73 WINDSOR ROAD,
    PRESTWICH, MANCHESTER, ENGLAND. M25 0DB.
    TEL +44 (0)161 721 4418
    MADE IN CHINA
    TO REPORT A SERIOUS ADVERSE
    EVENT CONTACT: 718 435 4444

    8 87901 00022 9

    Best used before end of

    Front Label

    Back Label

  • INGREDIENTS AND APPEARANCE
    ZOHAR FINEST ANTICAVITY 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55754-000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55754-000-00750 mL in 1 BOTTLE; Type 0: Not a Combination Product02/05/201402/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/05/201402/06/2022
    Labeler - Broom Lane Enterprises (216905611)

Related Drugs