FDA Label for Oxymetazoline Hydrochloride
View Indications, Usage & Precautions
Oxymetazoline Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Rebel Distributors Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Oxymetazoline HCl 0.05%
Purpose
Nasal decongestant
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Uses
temporary relief of nasal congestion
° due to the common cold
° due to hay fever or other upper respiratory allergies
° associated with sinusitis
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
Warnings
Do not exceed recommended dosage
This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.
Do not use for more than 3 days.
Ask a doctor before use if you have:
° heart disease ° high blood pressure
° thyroid disease ° diabetes
° difficulty in urination due to enlargement of the prostate gland
When using this product, frequent or prolonged use may cause nasal congestion to recur or worsen.
Stop use and ask a doctor if symptoms persist.
If pregnant or breast-feeding, ask a health professional before use.
Directions
° Adults and children 6 to under 12 years of age (with supervision): 2 to 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 the bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
Inactive Ingredients
benzalkonium chloride, dibasic sodium phosphate (anhydrous), edetate disodium (dihydrate), monobasic sodium phosphate (monohydrate), polyethylene glycol 1450, povidone, propylene glycol, purified water.
Questions? Cal 1-866-923-4914
Package/Label Principal Display Panel
* Please review the disclaimer below.
