Oxymetazoline monograph PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Oxymetazoline monograph PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Hi, i just want to inquire about the active ingredient oxymetazoline.
In the document PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
For products containing oxymetazoline hydrochloride identified in § 341.20(b)(7) —
(A) Nasal drops or sprays —
(1) For a 0.05-percent aqueous solution. Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age: consult a doctor.
(2) A 0.025-percent aqueous solution in a container having either a calibrated dropper or a metered-dose spray that delivers no more than 0.027 milligrams of oxymetazoline per three drops or three sprays. Children 2 to under 6 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 10 to 12 hours. Use only recommended amount. Do not exceed 2 doses in any 24-hour period. [previous two sentences in boldface type] Children under 2 years of age: consult a doctor.
May i know if there is a dosage limit in ug for 0.05% ? and may i know which clinical evidence that you used to support the maximum dosage 0.027 milligrams of oxymetazoline per three drops or three sprays for 0.025% ?
i hope to get some clarity on this.
Looking forward your reply.
Thanks!
Hi, i just want to inquire about the active ingredient oxymetazoline.
In the document PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
For products containing oxymetazoline hydrochloride identified in § 341.20(b)(7) —
(A) Nasal drops or sprays —
(1) For a 0.05-percent aqueous solution. Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age: consult a doctor.
(2) A 0.025-percent aqueous solution in a container having either a calibrated dropper or a metered-dose spray that delivers no more than 0.027 milligrams of oxymetazoline per three drops or three sprays. Children 2 to under 6 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 10 to 12 hours. Use only recommended amount. Do not exceed 2 doses in any 24-hour period. [previous two sentences in boldface type] Children under 2 years of age: consult a doctor.
May i know if there is a dosage limit in ug for 0.05% ? and may i know which clinical evidence that you used to support the maximum dosage 0.027 milligrams of oxymetazoline per three drops or three sprays for 0.025% ?
i hope to get some clarity on this.
Looking forward your reply.
Thanks!
Answer
Sorry for the delayed response. Your question was sent to our spam folder by mistake.
For questions about dosage and testing related to this FDA regulation, contact the FDA Center for Drug Evaluation and Research. Their contact information is available at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-contact-information
I hope this information is helpful. If this is not what you need, or if you should require any further assistance, please let us know.
Bobby Griffith
Lead Government Information Reference Associate
Sycamore Library
University of North Texas Libraries