OXYMETAZOLINE HYDROCHLORIDE solution

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 HCI 0.05% ....... Nasal decongestant

PURPOSE

• Rapid & Powerful Congestion Relief

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

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.

PREGNANCY OR BREAST FEEDING

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 turn 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 tilting 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° -25°C (68°-77 °F)
• retain carton for future reference on full labeling

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

Inactive ingredients

avicel, benzalkonium chloride, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium dihydrate, eucalyptol, menthol, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Bayer HealthCare LLC mdistributor of Afrin No Drip Severe Congestion

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OXYMETAZOLINE HYDROCHLORIDE 
oxymetazoline hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-608
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 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTOL (UNII: RV6J6604TK)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-608-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/15/2021

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Registrant - Seaway Pharma Inc. (117218785)

Establishment
Name	Address	ID/FEI	Business Operations
Seaway Pharma Inc.		117218785	manufacture(63868-608)