Label: OXYMETAZOLINE HCL- oxymetazoline hydrochloride spray
- NDC Code(s): 45802-410-59
- Packager: Perrigo New York Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient
Oxymetazoline hydrochloride 0.05%Close
- temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
- shrinks swollen nasal membranes so you can breathe more freely
Ask a doctor before use if you have
- heart disease
- high blood pressure
- 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
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- 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.Close
- 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, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasicClose
- Principal Display Panel
Compare to Afrin® active ingredient
Oxymetazoline HCl 0.05%
Fast, Powerful Congestion Relief
12 Hour Relief
Oxymetazoline HCl 0.05% Carton Image 1
Oxymetazoline HCl 0.05% Carton Image 2
- INGREDIENTS AND APPEARANCE
oxymetazoline hydrochloride spray
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45802-410 Route of Administration NASAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE 0.05 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE BENZYL ALCOHOL EDETATE DISODIUM POLYETHYLENE GLYCOLS POVIDONE PROPYLENE GLYCOL WATER SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 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:45802-410-59 1 in 1 CARTON 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 12/05/2005 Labeler - Perrigo New York Inc (078846912)