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NDC 27017-0018-01 Xlear Nasal Decongestant 0.0005 g/g Details
Xlear Nasal Decongestant 0.0005 g/g
Xlear Nasal Decongestant is a NASAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Xlear Inc.. The primary component is OXYMETAZOLINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymetazoline nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should use oxymetazoline nasal spray carefully and under adult supervision. Oxymetazoline is in a class of medications called nasal decongestants. It works by narrowing the blood vessels in the nasal passages.
Related Packages: 27017-0018-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Oxymetazoline Nasal Spray
Product Information
| NDC | 27017-0018 |
|---|---|
| Product ID | 27017-018_b8106b76-2793-4ed9-99c8-5ddab5b50d2c |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Xlear Nasal Decongestant |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Nasal Spray |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | NASAL |
| Active Ingredient Strength | 0.0005 |
| Active Ingredient Units | g/g |
| Substance Name | OXYMETAZOLINE HYDROCHLORIDE |
| Labeler Name | Xlear Inc. |
| Pharmaceutical Class | Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 27017-0018-01 (27017001801)
| NDC Package Code | 27017-018-01 |
|---|---|
| Billing NDC | 27017001801 |
| Package | 1 g in 1 BOTTLE, SPRAY (27017-018-01) |
| Marketing Start Date | 2019-03-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1c1db71a-47d0-42ac-8cbe-95e76dca185f Details
SPL UNCLASSIFIED SECTION
The use of this container by morethan one person may spread infection. Keep out of reach of children. Clean nozzle after each use and replace the cap. Do not exceed recommended dosage. Do not use this product for more than 3 days. If pregnant or breast-feeding, ask a health professional before use. Ask a physician before use if you have, heart disease, highblood pressure, thyroid disease, diabetes, trouble unitnating due to enlarged prostate gland. Not for children under age 6 unless directed by a physician.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Shake well before using. The metered pump sprayer provides a precise amount of soothing spray in a fine mist. Claer the nasal passage-way by gently blowing your nose before using. Prior to initial use, remove cap, prime the pump by holding it upright and pumping one or more times until the solution is dispensed. Insert nozzle into nostirl and depress pump completely while breathing in through the nose. Clean nozzle after use. Ages 6 years to adult (with adult supervision) - spray 1-2 times in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
SPL UNCLASSIFIED SECTION
The use of this container by more than one person may spread infection. Keep out of reach of children. Clean nozzle after each use and replace the cap. Do not exceed recommended dosage. Do not use this product for more than 3 days. If pregnant or breast-feeding, ask a health professional before use. Ask a physician before use if you have, heart disease, highblood pressure, thyroid disease, diabetes, trouble unitnating due to enlarged prostate gland. Not for children under age 6 unless directed by a physician.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Shake well before using. The metered pump sprayer provides a precise amount of soothing spray in a fine mist. Claer the nasal passage-way by gently blowing your nose before using. Prior to initial use, remove cap, prime the pump by holding it upright and pumping one or more times until the solution is dispensed. Insert nozzle into nostirl and depress pump completely while breathing in through the nose. Clean nozzle after use. Ages 6 years to adult (with adult supervision) - spray 1-2 times in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
PRINCIPAL DISPLAY PANEL
The use of this container by more than one person may spread infection. Keep out of reach of children. Clean nozzle after each use and replace the cap. Do not exceed recommended dosage. Do not use this product for more than 3 days. If pregnant or breast-feeding, ask a health professional before use. Ask a physician before use if you have, heart disease, highblood pressure, thyroid disease, diabetes, trouble unitnating due to enlarged prostate gland. Not for children under age 6 unless directed by a physician.
INGREDIENTS AND APPEARANCE
| XLEAR NASAL DECONGESTANT
nasal spray liquid |
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| Labeler - Xlear Inc. (839884058) |
| Registrant - Xlear Inc. (839884058) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Xlear Inc. | 839884058 | manufacture(27017-018) | |