Label: CORINZ- cetylpyridinium chloride rinse

  • NDC Code(s): 53462-375-07, 53462-375-30, 53462-375-60
  • Packager: Sage Products, LLC
  • 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 April 13, 2022

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  • Drug Facts

    Active ingredient: Purpose
    CORINZ ANTISEPTIC CLEANSING AND MOISTURIZING ORAL RINSE:
    Cetylpyridinium chloride 0.05%Antiseptic Rinse
  • Use

    Helps reduce chance of infection in minor oral irritation.

  • 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 times 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 dentist or doctor.
  • Inactive ingredients

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

  • Questions?

    800-323-2220.

  • SPL UNCLASSIFIED SECTION

    NOT MADE WITH NATURAL RUBBER LATEX • MADE IN U.S.A.

  • Corinz

    Corinz CupCorinz Packet (7 mL)

    Corinz Bottle (44 mL)

  • INGREDIENTS AND APPEARANCE
    CORINZ 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem 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 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53462-375-607 mL in 1 PACKET; Type 0: Not a Combination Product01/20/2015
    2NDC:53462-375-077 mL in 1 CUP; Type 0: Not a Combination Product07/22/2019
    3NDC:53462-375-3044 mL in 1 BOTTLE; Type 0: Not a Combination Product04/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/20/2015
    Labeler - Sage Products, LLC (054326178)
    Registrant - Sage Products, LLC (054326178)
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