OXYMETAZOLINE HCl by PURINEPHARMA LLC OXYMETAZOLINE HCL spray

OXYMETAZOLINE HCl by

Drug Labeling and Warnings

OXYMETAZOLINE HCl by is a Otc medication manufactured, distributed, or labeled by PURINEPHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Oxymetazoline HCl 0.05%

PURPOSE

Purpose: Nasal Decongestant

INDICATIONS & USAGE

Uses
Temporarily relieves nasal congestion due to:

• common cold
• hay fever
• upper respiratory allergies
• sinusitis
• shrinks swollen nasal membrances so you can breathe more freely.

WARNINGS

Ask a doctor before use if you have

• 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.

WHEN USING

When using this product

• Frequent or prolonged use may cause nasal congestion to rcur or worsen
• temporary discomfort such as buming, stinging, sneezing or an increase in nasal discharge may occur
• use of this container by more than one person may spread infection

PREGNANCY OR BREAST FEEDING

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.

DOSAGE & ADMINISTRATION

Directions: Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostrill not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
Children under six 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.

STORAGE AND HANDLING

Store between 20°C to 25°C (68° to 77° F)

Retain carton for future reference on full labeling.

INACTIVE INGREDIENT

Purified Water, Edetate Disodium, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Povidone, Benzalkonium Chloride Solution, Polyethylene Glycol, Propylene Glycol

HOW SUPPLIED

NDC: 58599-027-01: 30 mL in a Bottle, NDC: 58599-027-17: 15 mL in a Bottle

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OXYMETAZOLINE HCL 
oxymetazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58599-027
Route of Administration	ORAL, Type 0: Not a Combination Product

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
POVIDONE K90 (UNII: RDH86HJV5Z)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58599-027-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE
2	NDC: 58599-027-17	1 in 1 CARTON
2		15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/09/2015

Labeler - PURINEPHARMA LLC (019950491)

Registrant - PURINEPHARMA LLC (019950491)

Establishment
Name	Address	ID/FEI	Business Operations
PURINEPHARMA LLC		019950491	manufacture(58599-027)