Source: FDA, National Drug Code (US) Revision Year: 2020
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 |
| Drug | Countries | |
|---|---|---|
| DYCLOPRO | United States |
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