DYCLOPRO Topical solution Ref.[10046] Active ingredients: Dyclonine

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

DycloPro (Dyclonine Hydrochloride Topical Solution, USP, 0.5% and 1%) topical anesthetics contain a local anesthetic agent and are administered topically. See INDICATIONS for specific uses.

DycloPro (Dyclonine Hydrochloride Topical Solution, USP, 0.5% and 1%) contain dyclonine HCl, which is chemically designated as 4'-butoxy-3-piperidinopropiophenone HCl. Dyclonine HCl is a white crystalline powder that is sparingly soluble in water and has the following structural formula:

Composition of Dyclonine HCl Topical Solution, USP, 0.5% and 1% topical anesthetics:

Each mL of Dyclonine HCl Topical Solution, USP, 0.5% contains dyclonine HCl, 5 mg.

Each mL of Dyclonine HCl Topical Solution, USP, 1% contains dyclonine HCl, 10 mg.

Both solutions also contain chlorbutanol hydrous and sodium chloride, and the pH is adjusted 3.0-5.0 by means of hydrochloric acid.

How Supplied

Clear and colorless sterile solution, in one fluid ounce bottles.

Multi dose

Dyclonine HCl Topical Solution 0.5% (NDC 0362-3971-05)

Dyclonine HCl Topical Solution 1% (NDC 0362-3918-10)

Manufactured for SEPTODONT, Inc., 205 Granite Run Dr., Suite 150, Lancaster, PA, USA 17601

by Novocol Pharmaceuitcal of Canada, Inc., Ontario, Canada N1R 6X3

Drugs

Drug Countries
DYCLOPRO United States

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