SOUND BODY 12 HOUR NASAL ORIGINAL- oxymetazoline hydrochloride spray

Sound Body 12 Hour Nasal by

Drug Labeling and Warnings

Sound Body 12 Hour Nasal by is a Otc medication manufactured, distributed, or labeled by Lee Pharmaceuticals, Samson Pharmaceuticals. 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, sinusitis, upper respiratory allergies. 
• Shrinks swollen membranes so you can breathe more freely.

Warnings

Ask a doctor before use if you have

• Heart disease
• High blood pressure
• Diabetes
• Thyroid disease
• 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 persists.

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 ofter than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: consult a doctor.
• To spray, squeeze bottle quickly and firmly.  Do not tilt head backwards while spraying. Wipe nozzle clean after use.

Other information

• Store between 20° - 25° C (68° - 77° F)
• Retain carton for future reference on full labeling.

Inactive ingredients

Benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOUND BODY 12 HOUR NASAL  ORIGINAL
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23558-5120
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	50.0 mg  in 100.0 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23558-5120-0	1 in 1 CARTON
1	NDC: 23558-5120-1	30 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/31/2008

Labeler - Lee Pharmaceuticals (056425432)

Registrant - Lee Pharmaceuticals (056425432)

Establishment
Name	Address	ID/FEI	Business Operations
Samson Pharmaceuticals		088169581	manufacture(23558-5120)