NASAL- oxymetazoline hydrochloride spray 
Kroger Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Kroger Co. Nasal Spray Drug Facts

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. (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

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistance.

Other information

store at 20-25°C (68-77°F)
retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, monobasic sodium phosphate, polysorbate 80, propylene glycol, purified water

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of AFRIN® SINUS NASAL SPRAY

See side panel

SEE NEW DIRECTIONS

Nasal Spray

Nasal Decongestant

SINUS

Oxymetazoline Hydrochloride 0.05%

Fast, Powerful Congestion Relief

Relieves Painful Sinus Pressure

For Colds & Allergies

1 FL OZ (30 mL)

12 HOUR

Nasal Spray Image 1
Nasal Spray Image 2
NASAL 
oxymetazoline hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-817
Route of Administration NASAL DEA Schedule     
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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EUCALYPTOL (UNII: RV6J6604TK)  
MENTHOL (UNII: L7T10EIP3A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:30142-817-10 1 in 1 CARTON
1 30 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/24/2001
Labeler - Kroger Company (006999528)

Revised: 11/2014
Document Id: d315595b-515c-42a8-9b75-d51fee27a182
Set id: 368bdecb-5103-49e0-bbf5-e4ede34bcdaf
Version: 2
Effective Time: 20141119
 
Kroger Company