Oxymetazoline Hydrochloride
Spray · Nasal, Topical
Uses
Oxymetazoline hydrochloride cream is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. Oxymetazoline hydrochloride cream is an alpha 1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. ( 1 )
Dosage and administration
For topical use only. Oxymetazoline hydrochloride is not for oral, ophthalmic, or intravaginal use. Apply a pea-sized amount of oxymetazoline hydrochloride cream, once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips. Wash hands immediately after applying oxymetazoline hydrochloride cream. Not for oral, ophthalmic, or intravaginal use. ( 2 ) Apply a pea-sized amount once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips. ( 2 ) Wash hands after application. ( 2 )
Storage
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Label text from the FDA structured product label by Sun Pharmaceutical Industries, Inc. (revised May 8, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Oxymetazoline Hydrochloride in 9 products
Oxymetazoline Hydrochloride NDC products (9)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 51672-1405 | Oxymetazoline Hydrochloride 10 mg/g Cream | Sun Pharmaceutical Industries, Inc. | ANDA |
| 37835-996 | Oxymetazoline Hydrochloride .05 g/100mL Spray | Bi-Mart | OTC MONOGRAPH DRUG |
| 63868-608 | Oxymetazoline Hydrochloride .05 mg/mL Solution | CHAIN DRUG MARKETING ASSOCIATION INC | OTC MONOGRAPH DRUG |
| 63868-605 | Oxymetazoline Hydrochloride .05 g/100mL Spray | CHAIN DRUG MARKETING ASSOCIATION INC. | OTC MONOGRAPH DRUG |
| 63868-607 | Oxymetazoline Hydrochloride .05 g/100mL Spray | CHAIN DRUG MARKETING ASSOCIATION INC. | OTC MONOGRAPH DRUG |
| 63868-676 | Oxymetazoline Hydrochloride .05 g/100mL Spray | CHAIN DRUG MARKETING ASSOCIATION INC. | OTC MONOGRAPH DRUG |
| 68071-3422 | Oxymetazoline Hydrochloride .05 g/100mL Spray | NuCare Pharmaceuticals,Inc. | OTC MONOGRAPH DRUG |
| 68210-5056 | Oxymetazoline Hydrochloride .05 g/100mL Spray | Prodose, Inc. | OTC MONOGRAPH DRUG |
| 51672-2030 | Oxymetazoline Hydrochloride .05 g/100mL Spray | Sun Pharmaceutical Industries, Inc. | OTC MONOGRAPH DRUG |
Oxymetazoline Hydrochloride recalls
- D-0214-2024 Jan 10, 2024 · Class II · Ongoing
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. - D-0216-2024 Jan 10, 2024 · Class II · Ongoing
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. - D-0217-2024 Jan 10, 2024 · Class II · Ongoing
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Frequently asked questions
What is Oxymetazoline Hydrochloride used for?
Oxymetazoline hydrochloride cream is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. Oxymetazoline hydrochloride cream is an alpha 1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. ( 1 )
Who makes Oxymetazoline Hydrochloride?
Oxymetazoline Hydrochloride is listed by 6 labelers in the FDA NDC directory, including Sun Pharmaceutical Industries, Inc., Bi-Mart, CHAIN DRUG MARKETING ASSOCIATION INC, CHAIN DRUG MARKETING ASSOCIATION INC..
Has Oxymetazoline Hydrochloride been recalled?
The FDA enforcement database lists 3 recalls for Oxymetazoline Hydrochloride, most recently D-0214-2024 (class ii): CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in…