NASAL- oxymetazoline hydrochloride spray

Nasal by

Drug Labeling and Warnings

Nasal by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

• for the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• shrinks swollen membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland

When using this product

• 1. do not exceed recommended dosage
• 2. do not use for more than 3 days. Use only as directed.
• 3. may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
• 4. the use of this container by more than one person may spread infection
• 5. frequent or prolonged use may cause nasal congestion to recur or worsen

Stop use and ask doctor if symptoms persist.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours
• do not exceed 2 doses within any 24-hour period
• children under 6 years of age: consult a doctor

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use

Other information

STORAGE AND HANDLING

• store between 20° to 25° C (68° to 77° F)

Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hydrochloric acid, monobasic sodium phosphate, polyethylene glycol 1450, povidone, propylene glycol, purified water

Questions?

To Report Adverse Drug Event Call: (800) 616-2471

PRINCIPAL DISPLAY PANEL - 15 mL Carton

NDC: 63187-701-15

Relabeled by:

Proficient Rx LP, Thousand Oaks, CA 91320

Soothing - 12 Hour
NASAL
DECONGESTANT
Spray

REGULAR

oxymetazoline
hydrochloride
0.05%

RELIEVES
CONGESTION
FAST

Compare to
active ingredient
of Afrin®

1/2 FL.OZ.
(15 mL)

INGREDIENTS AND APPEARANCE

NASAL 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-701(NDC:0904-5711)
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY)	Oxymetazoline Hydrochloride	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Edetate Disodium (UNII: 7FLD91C86K)
Propylene Glycol (UNII: 6DC9Q167V3)
Benzyl Alcohol (UNII: LKG8494WBH)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
Hydrochloric Acid (UNII: QTT17582CB)
Polyethylene Glycol 1450 (UNII: OJ4Z5Z32L4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-701-15	15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/02/2016
2	NDC: 63187-701-30	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/02/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/17/2009

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	RELABEL(63187-701)