Label: SINUFRIN PLUS NEILMED- oxymetazoline hydrochloride spray
- NDC Code(s): 13709-232-05, 13709-232-06, 13709-232-12
- Packager: NeilMed Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 11, 2024
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- Active Ingredients
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Warnings
- Do not use this product for more than 3 consecutive days.Use only as directed.
- Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.
- Do not use this product if you have heart disease, high blood pressure, thyroid disease or diabetes unless directed by a doctor.
- Directions for Dosing
- Uses
- Other Information
- Warnings
- DO NOT USE
- Other Information
- Warnings
- Warnings
- Warnings
- Inactive ingredients
- uses
- Principle Display
- Box Label
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INGREDIENTS AND APPEARANCE
SINUFRIN PLUS NEILMED
oxymetazoline hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13709-232 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 7.5 mg in 15 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) SODIUM BICARBONATE (UNII: 8MDF5V39QO) GLYCERIN (UNII: PDC6A3C0OX) ALOE (UNII: V5VD430YW9) ALLANTOIN (UNII: 344S277G0Z) HYDROCHLORIC ACID (UNII: QTT17582CB) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13709-232-06 15 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 07/15/2012 2 NDC:13709-232-05 15 mL in 1 BOX; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 07/15/2012 3 NDC:13709-232-12 1 in 1 CARTON 04/21/2021 3 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/15/2012 Labeler - NeilMed Pharmaceuticals, Inc. (799295915) Establishment Name Address ID/FEI Business Operations NeilMed Pharmaceuticals, Inc. 799295915 manufacture(13709-232)