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OXYMETAZOLINE HYDROCHLORIDE by Rebel Distributors Corp

Medically reviewed on Feb 21, 2018

Dosage form: spray, metered
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.5mg in 1mL
Labeler: Rebel Distributors Corp
NDC Code: 21695-875

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.

Nasal Decongestant Drug Facts

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

OXYMETAZOLINE HYDROCHLORIDE 
oxymetazoline hydrochloride spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-875(NDC:51672-2030)
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
SODIUM PHOSPHATE, DIBASIC ANHYDROUS 
EDETATE DISODIUM 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
POLYETHYLENE GLYCOL 1450 
POVIDONE 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:21695-875-1515 mL in 1 BOTTLE, SPRAY
2NDC:21695-875-3030 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/11/2008
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

 
Rebel Distributors Corp

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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