- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
-
When using this product
- do not use more than directed
- do not use for more than 3 days. Use only as directed. Frequent 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
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Keep out of reach of children
-
Directions
- adults and children 6 to under 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. Before using the first time, remove the protective cap from the tip and prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Container and Carton Labels
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INGREDIENTS AND APPEARANCE
OXYMETAZOLINE HYDROCHLORIDE
oxymetazoline hydrochloride spray, meteredProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68382-418 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 EDETATE DISODIUM (UNII: 7FLD91C86K) EUCALYPTOL (UNII: RV6J6604TK) GLYCINE (UNII: TE7660XO1C) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) MENTHOL (UNII: L7T10EIP3A) CAMPHOR (NATURAL) (UNII: N20HL7Q941) Product Characteristics Color WHITE (COLORLESS) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68382-418-07 1 in 1 CARTON 1 22 mL in 1 INHALER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part341 09/24/2009 Labeler - Zydus Pharmaceuticals (USA) Inc. (156861945) Registrant - Zydus Pharmaceuticals (USA) Inc. (156861945) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 Analysis, Manufacture