Label: OXYMETAZOLINE HCL spray
Contains inactivated NDC Code(s)
NDC Code(s): 71027-013-02, 71027-013-17
- Packager: KINGSTON PHARMA LLC
- Category: HUMAN OTC DRUG LABEL
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.
Updated March 1, 2017
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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
INGREDIENTS AND APPEARANCE
oxymetazoline hcl spray
Product 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)