OXYMETAZOLINE HCl by KINGSTON PHARMA LLC OXYMETAZOLINE HCL spray

OXYMETAZOLINE HCl by

Drug Labeling and Warnings

OXYMETAZOLINE HCl by is a Otc medication manufactured, distributed, or labeled by KINGSTON PHARMA 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)

INACTIVE INGREDIENT

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

HOW SUPPLIED

(pack: 30ml) Kingston NDC# 71027-013-02
(pack: 15ml) Kingston NDC# 71027-013-17

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OXYMETAZOLINE HCL 
oxymetazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71027-013
Route of Administration	ORAL

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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
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: 71027-013-02	1 in 1 CARTON	03/01/2017
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 71027-013-17	1 in 1 CARTON	03/01/2017
2		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2017

Labeler - KINGSTON PHARMA LLC (080386521)

Registrant - KINGSTON PHARMA LLC (080386521)

Establishment
Name	Address	ID/FEI	Business Operations
KINGSTON PHARMA LLC		080386521	manufacture(71027-013)