NASAL- oxymetazoline hydrochloride spray

NASAL by

Drug Labeling and Warnings

NASAL by is a Otc medication manufactured, distributed, or labeled by Bi-Mart, SEAWAY PHARMA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

• temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
• temporarily relieves sinus congestion and pressure
• shrinks swollen nasal 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 an enlarged prostate gland

When using this product

• do not use more than directed
• do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
• use of this container by more than one person may spread infection

Stop use and ask a doctor ifsymptoms 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 in any 24-hour period.
• children under 6 years of age:ask a doctor.
• to spray: squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other information

• do not use if seal around cap is missing or damaged
• save carton for complete information
• store between 20° to 25°C (68°F and 77°F)

Inactive ingredients

benzalkonium chloride solution, dibasic sodium phosphate, edetate disodium dihydrate, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water.

Questions?

call toll-free 1-800-935-6737

Distributed by:

BI-MART

Eugene, OR 97402

*This product is not manufactured or distributed by the owner of the registered trademark Afrin ®

PRINCIPAL DISPLAY PANEL

BI-MART

*Compare to the active ingredient in Afrin ®

LONG LASTING

NASAL SPRAY

Oxymetazoline hydrochloride 0.05%

NASAL DECONGESTANT

FAST CONGESTION RELIEF FOR UP TO 12 HOURS

RELIEVES NASAL CONGESTION DUE TO COLDS AND ALLERGIES

1 FL. OZ. (30 mL)

INGREDIENTS AND APPEARANCE

NASAL 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-995
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-995-34	1 in 1 CARTON	05/16/2024
1		30 mL in 1 BOTTLE, SPRAY; 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	05/16/2024

Labeler - Bi-Mart (027630078)

Establishment
Name	Address	ID/FEI	Business Operations
SEAWAY PHARMA		117218785	manufacture(37835-995)