Label: ADVANCED GUARD- cetylpyridinium chloride rinse
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- NDC Code(s): 37808-509-45
- Packager: H-E-B
- 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 June 28, 2022
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- claims
- Active Ingredient
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- Warnings
- Stop use and ask a dentist if
- Keep out of reach of children
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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
- Questions
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- Adverse Reactions Section
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INGREDIENTS AND APPEARANCE
ADVANCED GUARD
cetylpyridinium chloride rinseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-509 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 1 mg in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) SUCRALOSE (UNII: 96K6UQ3ZD4) POLOXAMER 407 (UNII: TUF2IVW3M2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-509-45 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/25/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/25/2013 Labeler - H-E-B (007924756) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(37808-509) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(37808-509)
