Label: OXYMETAZOLINE HYDROCHLORIDE spray, metered
Contains inactivated NDC Code(s)
NDC Code(s): 21695-875-15, 21695-875-30
- Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 51672-2030
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 21, 2011
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- Official Label (Printer Friendly)
- Active ingredient
- Keep Out of Reach of Children
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.
° 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
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
oxymetazoline hydrochloride spray, metered
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-875(NDC:51672-2030) Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-875-15 15 mL in 1 BOTTLE, SPRAY 2 NDC:21695-875-30 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 12/11/2008 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK