PHARIXIA Mouthwash Ref.[49694] Active ingredients: Benzydamine

Source: Health Products and Food Branch (CA)  Revision Year: 2019 

Product name

PHARIXIA – Benzydamine Mouthwash, BP

Benzydamine hydrochloride 1.5 mg/mL (0.15% w/v)

Summary product information

Route of AdministrationDosage Form / StrengthAll Nonmedicinal Ingredients
Oral (Buccal) Mouthwash / 1.5 mg/mL (0.15% w/v) Alcohol, Citric Acid Anhydrous, Glycerin, Methylparaben, Natural and Artificial Mouthwash Aroma (Water, Ethyl Alcohol, Natural & Artificial flavour, Polysorbate, Propylene Glycol, D&C Yellow No. 10 and FD&C Blue No. 1), Polysorbate 80, Propylparaben, Purified Water, Sodium Citrate Dihydrate, Sorbitol Solution.
Oral (Buccal) Mouthwash / 1.5 mg/mL (0.15% w/v) (Alcohol-Free) Citric Acid Anhydrous, Glycerin, FD&C Yellow No. 6, FD&C Red No. 40, Methylparaben, Natural Orange Flavour (contains Modified Corn Starch, Corn Syrup, Maltodextrin, Citric Acid, BHT), Polysorbate 80, Propylparaben, Purified Water, Sodium Citrate Dihydrate, Sorbitol Solution.

Dosage forms, composition and packaging

PHARIXIA (1.5 mg/mL; 0.15% (w/v) mouthwash) is available in PET bottles containing 250 mL of a clear, yellow-green liquid with a distinctive mint-like odour.

Nonmedicinal Ingredients: Alcohol, Citric Acid Anhydrous (for pH adjustment), Glycerin, Methylparaben, Natural and Artificial Mouthwash Aroma, Polysorbate 80, Propylparaben, Purified Water, Sodium Citrate Dihydrate (for pH adjustment), Sorbitol Solution.

Natural and Artificial Mouthwash Aroma contains: Water, Ethyl Alcohol, Natural & Artificial flavour, Polysorbate, Propylene Glycol, D&C Yellow No. 10 and FD&C Blue No. 1

PHARIXIA ALCOHOL FREE (1.5 mg/mL; 0.15% (w/v) mouthwash) is available in PET bottles containing 250 mL of a clear light-orange solution.

Nonmedicinal Ingredients: Citric Acid Anhydrous (for pH adjustment), Glycerin, FD&C Yellow No. 6, FD&C Red No. 40, Methylparaben, Natural Orange Flavour, Polysorbate 80, Propylparaben, Purified Water, Sodium Citrate Dihydrate (for pH adjustment), Sorbitol Solution.

Natural Orange Flavour contains: Modified Corn Starch, Corn Syrup, Maltodextrin, Citric Acid, BHT

Marketing Informations Authorization Dates
Authorization holder:

PENDOPHARM, Division of Pharmascience Inc., 6111 Royalmount Avenue Suite #100, Montreal, Québec, H4P 2T4

Submission control number:

226851

Date of revision:

November 27, 2019

Drugs

Drug Countries
PHARIXIA Canada, Hong Kong

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