Label: SINUFRIN PLUS NEILMED- oxymetazoline hydrochloride spray
- NDC Code(s): 13709-232-05, 13709-232-06
- Packager: NeilMed Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CII
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredients
0.05% Oxymetazoline HydrochlorideClose
- 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
* Adults and children 6 to 12 years of age (with adult supervision): Per dose, 2 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.Close
* Children under 6 years of age: consult a doctor
Temporarily relieves nasal congestion due to common cold, sinus infections, hay fever, upper respiratory allergies.Close
- Other Information
Store between 20 to 40 °C (68 to 104 °F)Close
Retain carton for future reference on full labeling
KEEP OUT OF REACH OF CHILDREN. If Swallowed,get medical help or contact a Poison Control Center right away.Close
- DO NOT USE
Do not use this product for more than 3 consecutive days.Close
Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.
- Other Information
- Keep head in an upright position for use.
- Do not tilt head backward while spraying.
- Wipe nozzle clean after each use.
Stop use and ask a doctor if symptoms of nasal congestion persist after 3 days.Close
Adult males with prostate disease, do not use this product.
If pregnant or breast-feeding, ask health care professional before use.Close
This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.Close
The use of this container by more than one person may spread infection.
- Inactive ingredients
Propylene glycol, glycerin, sodium chloride, hyaluronic acid, aloe vera, allantoin, sodium bicarbonate USP, benzalkonium chloride, edetate disodium, purified waterClose
- Principle Display
Imag of BottleClose
- Box Label
temporarily relieves nasal congestion due to:
upper respiratory allergiesClose
- INGREDIENTS AND APPEARANCE
SINUFRIN PLUS NEILMED
oxymetazoline hydrochloride spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13709-232 Route of Administration NASAL DEA Schedule CII 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) 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) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/15/2012 Labeler - NeilMed Pharmaceuticals, Inc. (783557783) Establishment Name Address ID/FEI Business Operations NeilMed Pharmaceuticals, Inc. 799295915 manufacture(13709-232)