Label: SUCTION TOOTHBRUSH WITH CORINZ ORAL RINSE- cetylpyridinium chloride kit

  • Category: HUMAN OTC DRUG LABEL

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 April 3, 2018

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  • Use

    Helps reduce chance of infection in minor oral irritation.

  • Drug Facts

     Active Ingredient:    Purpose
     Cetylpyridinium chloride 0.05% Antiseptic Rinse

  • INDICATIONS & USAGE

  • Warnings

    Stop use and ask a doctor if:


    • Sore mouth symptoms do not improve in 7 days.
    • Swelling, rash or fever develops.
    • Irritation, pain or redness persists or worsens.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

  • Directions

    • Use up to 4 time daily or as directed by a dentist or doctor.
    • Adults and children 3 years and older: rinse mouth with 1/2 Tbsp. for approx. one minute. Instruct to expectorate.
    • Children under 3 years of age: consult a doctor.
  • Inactive Ingredients

    Water, glycerin, xylitol, spearmint flavor, potassium sorbate, polysorbate 20, polysorbate 80m, hyrdroxyethylcellulose, citric acid, sodium saccharin, menthol.

  • Questions?

    Call toll-free 800-323-2220

  • SPL UNCLASSIFIED SECTION

    NOT MADE WITH NATURAL RUBBER LATEX 

    MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    6561 label

    Corinz packet

  • INGREDIENTS AND APPEARANCE
    SUCTION TOOTHBRUSH WITH CORINZ ORAL RINSE 
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-561
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-561-601 in 1 KIT; Type 1: Convenience Kit of Co-Package01/24/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 7 mL
    Part 2 1 
    Part 1 of 2
    CORINZ 
    cetylpyridinium chloride rinse
    Product Information
    Item Code (Source)NDC:53462-375
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 KIT
    1NDC:53462-375-607 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/21/2000
    Part 2 of 2
    SODIUM BICARBONATE 
    other oral hygiene products
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    INGRSODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/24/2018
    Labeler - Sage Products, LLC (054326178)
    Registrant - Sage Products, LLC (054326178)
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