Label: LEADER ORIGINAL NASAL- oxymetazoline hydrochloride spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 49781-041-01 - Packager: Cardinal Health
- 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 November 7, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
-
WHEN USING
When using this product
- do not use more than directed
- do not use more than 3 days. Use only as directed. Frequesnt or prolonged use may cause nasal congestion to recur or worsen.
- temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur.
- use of this container by more than one person may spread infection.
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
Directions
- adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more 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.
- shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides in a counterclockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto the bottle.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LEADER ORIGINAL NASAL
oxymetazoline hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49781-041 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 0.05 mg in 100 mg Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) POVIDONE K30 (UNII: U725QWY32X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49781-041-01 1 in 1 CARTON 11/07/2016 1 30 mg in 1 BOTTLE, SPRAY; 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 08/29/2013 Labeler - Cardinal Health (097537435)
