- 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:71027-013 Route of Administration ORAL 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) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71027-013-02 1 in 1 CARTON 03/01/2017 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:71027-013-17 1 in 1 CARTON 03/01/2017 2 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/01/2017 Labeler - KINGSTON PHARMA LLC (080386521) Registrant - KINGSTON PHARMA LLC (080386521) Establishment Name Address ID/FEI Business Operations KINGSTON PHARMA LLC 080386521 manufacture(71027-013)