Label: ANTISEPTIC ORAL RINSE- cetylpyridinium chloride mouthwash
- NDC Code(s): 53462-175-60
- Packager: Sage Products LLC
- Category: HUMAN OTC DRUG LABEL
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Updated February 22, 2022
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- Active ingredient
- Sore mouth symptoms do not improve in 7 days.
- Swelling, rash or fever develops.
- Irritation, pain or redness persists or worsens.
- Use up to 4 times daily or as directed by a dentist or doctor.
- Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp., or use topically (dip into bottle) with clean Toothette ® Oral Swab. Instruct to expectorate.
- Children under 12 years of age: supervise use.
- Children under 3 years of age: consult a dentist or doctor.
- Inactive Ingredients
- Antiseptic Oral Rinse
INGREDIENTS AND APPEARANCE
ANTISEPTIC ORAL RINSE
cetylpyridinium chloride mouthwash
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53462-175 Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) PEPPERMINT (UNII: V95R5KMY2B) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYSORBATE 20 (UNII: 7T1F30V5YH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53462-175-60 7 mL in 1 PACKET; Type 0: Not a Combination Product 12/28/2001 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 06/21/2000 Labeler - Sage Products LLC (054326178)