EQUALINE OXYMETAZOLINE HCL NASAL DECONGESTANT NO DRIP- oxymetazoline hydrochloride spray

EQUALINE Oxymetazoline HCl Nasal Decongestant by

Drug Labeling and Warnings

EQUALINE Oxymetazoline HCl Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by SUPERVALU INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 if

symptoms 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 at 1-800-222-1222.

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.

Shake well before use. Before using the first time, remove the protective cap from the tip by pressing and twisting off the cap. Rotate the lock tab to align arrow marks to unlock the pump. Prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Lock the pump by ensuring that arrow marks are not aligned and replace the protective cap on tip.

Other information

• store between 20°to 25°C (68°to77°F)
• retain carton for future reference on full labeling.

Inactive ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, microcrystalline cellulose and carboxymethyl cellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.

Principal Display Panel

NDC: 41163-716-01

compare to Afrin® No-Drip Original active ingredient*

EQUALINE®

no drip

nasal spray

Oxymetazoline HCl 0.05%

(nasal decongestant)

• original 12 hour pump mist
• fast, powerful congestion relief

1 FL OZ (30 mL)

SAFETY SEALED: Do not use if imprinted seal on bottle is broken or missing

DISTRIBUTED BY SUPERVALU INC.

EDEN PRAIRIE, MN 55344 USA

*This product is not manufactured or distributed by Schering-Plough Healthcare Products, Inc., distributor of Afrin®No Drip Original.

SUPERVALU QUALITY Guaranteed

We’re committed to your satisfaction and guarantee the quality of this product.

Contact us at 1-877-932-7948, or

www.supervalu-ourownbrands.com.

Please have package available.

INGREDIENTS AND APPEARANCE

EQUALINE OXYMETAZOLINE HCL NASAL DECONGESTANT  NO DRIP
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-716
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)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONES (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (Translucent)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-716-01	1 in 1 CARTON	06/12/2015
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 final	part341	06/12/2015

Labeler - SUPERVALU INC (006961411)