Label: OXYMETAZOLINE HCL spray
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Contains inactivated NDC Code(s)
NDC Code(s): 58599-027-01, 58599-027-17 - Packager: PURINEPHARMA LLC
- 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 13, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions: Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostrill not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
Children under six 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.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OXYMETAZOLINE HCL
oxymetazoline hcl sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58599-027 Route of Administration ORAL, Type 0: Not a Combination Product 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 WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) POVIDONE K90 (UNII: RDH86HJV5Z) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58599-027-01 1 in 1 CARTON 1 30 mL in 1 BOTTLE 2 NDC:58599-027-17 1 in 1 CARTON 2 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/09/2015 Labeler - PURINEPHARMA LLC (019950491) Registrant - PURINEPHARMA LLC (019950491) Establishment Name Address ID/FEI Business Operations PURINEPHARMA LLC 019950491 manufacture(58599-027)