Label: CETYLPYRIDINIUM CHLORIDE - cetylpyridinium chloride mouthwash
- NDC Code(s): 53462-175-30, 53462-175-60
- Packager: Sage Products Inc.
- 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.
Updated March 22, 2012
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- ACTIVE INGREDIENT
Cetylpyridinium chloride .05%Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If more than used for rinsing or swabbing is accidentally swallowed, get medical help or contact a Poison Control Center right away.Close
- INDICATIONS & USAGE
Helps reduce chance of infection in minor oral irritation.Close
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.
- DOSAGE & ADMINISTRATION
- Use up to 4 times daily or as directed by a dentist or doctor.
- Adults and children 3 years and over: rinse mouth for approximately one minute with 1/2 Tbsp., or use topically (dip into bottle) with clean Toothette(R) 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 INGREDIENT
water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, FD and C Blue 1Close
- INGREDIENTS AND APPEARANCE
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:53462-175-30 44 mL in 1 BOTTLE, PLASTIC 2 NDC:53462-175-60 7 mL in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 12/28/2001 Labeler - Sage Products Inc. (054326178) Establishment Name Address ID/FEI Business Operations Sage Products Inc. 054326178 manufacture