Label: ADVANCED GUARD- 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 February 24, 2020

If you are a consumer or patient please visit this version.

  • claims

    H-E-B

    Alcohol Free

    ADVANCED

    GUARD

    ANTIGINGIVITIS/ANTIPLAQUE

    ORAL RINSE

    No more alcohol burn!

  • Active Ingredient

    Cetylpyridinium chloride 0.1%

  • purpose

    Antigingivitis, Antiplaque

  • Uses

    helps prevent plaque that leads to gingivitis

  • Warnings

    For this product

  • Stop use and ask a dentist if

    • gingivitis, bleeding, or redness persists for more than 2 weeks
    • you have painful or swollen gums, puss from the gum line, loose teeth or increased spacing between the teeth.  These may be signs or symptoms of periodontitis, a serious form of gum disease
  • 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 12 years of age and older: vigorously swish 20 mL (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out
    • do not swallow the rinse
    • children 6 years to under 12  years of age: supervise use
    • when used after brushing, rinse mouth with water first
    • children under 6 years of age: do not use
  • Inactive ingredients

    water, glycerin, hydrogen peroxide, flavor, sucralose, poloxamer 407

  • Questions

    Call 1-888-593-0593

  • Claims

    This rinse may cause temporary staining to the surface of teeth.  This is not harmful, and adequate brushing may prevent its occurrence.

  • Disclaimer

    This product is not manufactured or distributed by Proctor and Gamble, distributor of Crest Pro-Health Clinical Oral Rinse.

  • Adverse Reactions Section

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    MADE WITH PRIDE AND CARE FOR

    H-E-B, SAN ANTONIO, TX 78204

    509.000/509AA

  • principal display panel

    Compare to Crest Pro-Health Clinical Oral Rinse

    H-E-B

    Intense Mint

    Alcohol Free

    ADVANCED

    GUARD

    ANTIGINGIVITIS/ANTIPLAQUE

    ORAL RINSE

    • Helps prevent plaque & gingivitis
    • Hellps fight germs that cause bad breath
    • Helps keep teeth feeling clean with no alcohol burn

    MAXIMUM STRENGTH

    32 FL OZ (1 QT) 946 mL

    image description

  • INGREDIENTS AND APPEARANCE
    ADVANCED GUARD 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-509
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-509-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/25/2013
    Labeler - H-E-B (007924756)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(37808-509)