OXYMETAZOLINE HYDROCHLORIDE spray

OXYMETAZOLINE HYDROCHLORIDE by

Drug Labeling and Warnings

OXYMETAZOLINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG MARKETING ASSOCIATION INC., Seaway Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient                         Purpose

Oxymetazoline HCl 0.05%............. Nasal decongestant

PURPOSE

Nasal Decongestant

Uses

• temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
• shrinks swollen nasal membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

• heart disease 
• thyroid disease
• high blood pressure
• 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

Stop use and ask a doctor if symptoms persist.

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

KEEP OUT OF REACH OF CHILDREN

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 10-12 hours. Do not exceed 2 doses in any 24-hour period.
• children under 6 years of age: ask a doctor
• Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides and tum in a counter-clockwise direction and pull off to remove. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tiltlng the head insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap back onto the bottle.

Other information

• store between 20˚C to 25˚C (68˚F to 77˚F)
• retain carton for future reference on full labeling

Inactive ingredients

• No Drip Original Nasal Pump Mist- (NDC-63868-605-01) avicel. benzalkonium chloride, benzyl alcohol. dibasic sodium phosphate, edetate disodium dihydrate, flavor, monobasic sodium phosphate, polyethylene glycol, povidone, purified water
• No Drip Extra Moisturizing Nasal Pump Mist- (NDC-63868-676-01) avicel. benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium dihydrate, glycerin, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

SPL UNCLASSIFIED SECTION

• Tamper Evident: Do not use the product if the temper evident seal is broken or missing.
• This product is not manufactured or distributed by Bayer HealthCare LLC distributor of Afrin Original Nasal Spray.

Questions or comments?1-800-935-2362, Mon-Fri. 9 am-5 pm EST)

Distributed by C.D.M.A Inc.
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Question: 800-935-2362

PRINCIPAL DISPLAY PANEL

NDC-63868-605-01

NDC-63868-676-01

INGREDIENTS AND APPEARANCE

OXYMETAZOLINE HYDROCHLORIDE 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-605
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-605-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/01/2021

OXYMETAZOLINE HYDROCHLORIDE 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-676
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
glycerin (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-676-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/01/2021

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC. (011920774)

Registrant - Seaway Pharma Inc. (117218785)

Establishment
Name	Address	ID/FEI	Business Operations
Seaway Pharma Inc.		117218785	manufacture(63868-605, 63868-676)