NOSTRILLA- oxymetazoline hydrochloride spray, metered

Nostrilla by

Drug Labeling and Warnings

Nostrilla by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient (per spray)	Purpose
oxymetazoline hydrochloride 0.05% . . . . . . . . . . . . Nasal decongestant

Uses

for temporary relief of nasal congestion

• due to a cold
• due to hay fever or other upper respiratory allergies
• shrinks swollen membranes so you can breathe more freely

Warnings

For nasal use only. 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 exceed recommended dosage
• temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
• do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse.
• use only as directed

Stop use and ask a doctor if symptoms persist

The use of this container by more than one person may spread infection

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.

Directions

do not exceed 2 doses in any 24 hour period

• 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.
• children under 6 years of age: ask a doctor

Inactive Ingredients

benzalkonium chloride solution, camphor, carbomer 934P, carboxymethylcellulose sodium, edetate disodium, eucalyptol, glycine, hyaluronic acid sodium, menthol, polyethylene glycol, propylene glycol, sodium hydroxide, water.

PRINCIPAL DISPLAY PANEL - 1/2 FL. OZ. Bottle Carton

NASAL
DECONGESTANT

Nōstrilla®
oxymetazoline HCl USP 0.05%

COMPLETE
Congestion Relief

2 in 1 Formula
Relieves Severe
Congestion and
Moisturizes

No-Drip Formula

12 HOUR

1/2 FL. OZ.
(15 ML)

INGREDIENTS AND APPEARANCE

NOSTRILLA 
oxymetazoline hydrochloride spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-072
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY)	Oxymetazoline	0.0005 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
benzalkonium chloride (UNII: F5UM2KM3W7)
camphor (UNII: 5TJD82A1ET)
carboxymethylcellulose sodium (UNII: K679OBS311)
edetate disodium (UNII: 7FLD91C86K)
eucalyptol (UNII: RV6J6604TK)
glycine (UNII: TE7660XO1C)
menthol (UNII: L7T10EIP3A)
polyethylene glycol (UNII: 3WJQ0SDW1A)
propylene glycol (UNII: 6DC9Q167V3)
sodium hydroxide (UNII: 55X04QC32I)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-072-01	1 in 1 CARTON
1		15 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/08/2009

Labeler - Insight Pharmaceuticals (176792315)