Active Ingredient
Oxymetazoline HCl 0.05%
Oxymetazoline Hydrochloride
FDA Label NDC 21695-875
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Oxymetazoline Hydrochloride (NDC 21695-875). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Nasal Spray 0.05% (D0da5393 8c1d 48ce 85e6 22213f6a4ba2 01)
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