Label: REACH ANTI PLAQUE- cetylpyridinium chloride rinse

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 22, 2021

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  • Active ingredient

    Cetylpyridinium chloride 0.075%

  • Purpose

    Antigingivitis/antiplaque

  • Use

    helps prevent and reduce plaque and gingivitis

  • Warnings

    Do not use

    this product if gums are irritated or bleeding unless directed to do so by a doctor or dentist.

    Ask a dentist if

    symptoms persist or condition worsens after regular use.

    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

    •
    use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use

    Adults and children 6 years of age and older:

    •
    vigorously swish 20 mL of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow rinse.

    Children 6 years to under 12 years of age: supervise use

    Children under 6 years of age: do not use

  • Other information

    •
    this rinse is not intended to replace brushing or flossing
    •
    store at room temperature 59-86°F (15-30°C)
    •
    cold weather may temporarily cloud product, shake well if this occurs
    •
    do not use if printed safety seal is broken or missing
  • Inactive ingredients

    purified water, glycerin, propylene glycol, poloxamer 407, PEG-40 hydrogenated castor oil, flavor, sucralose, disodium phosphate, citric acid, D&C red #33, FD&C blue #1

  • Questions?

    1-866-373-7374 or comments@ranir.com

  • Package/Label Principal Display Panel

    REACH® ESSENTIALS™

    ANTI-PLAQUE

    Antigingivitis/Antiplaque Oral Rinse

    6 IN 1 BENEFITS

    - Kills Germs

    - Freshens Breath

    - Clean Mouth

    - Reduces Plaque

    - Fights Gingivitis

    - Alcohol-Free

    REFRESHING MINT

    13.5 FL OZ (400 mL)

    reach-antiplaque-front
    reach-anti-plaque-back
  • INGREDIENTS AND APPEARANCE
    REACH ANTI PLAQUE 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66923-002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66923-002-64400 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/16/2021
    Labeler - Ranir LLC (364567615)
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