Label: 12 HOUR NASAL- oxymetazoline hcl spray
- 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.
Updated January 2, 2018
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- Drug Facts
- Active Ingredient
- When using this product: do not use more than directed
- Stop use and ask a doctor
- If pregnant or breast feeding,
- Keep out of reach of children.
- adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril 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.
- Other Information
- Inactive Ingredients
- Questions or Comments?
- PRINCPAL DISPLAY PANEL - 15mL Bottle Carton
INGREDIENTS AND APPEARANCE
12 HOUR NASAL
oxymetazoline hcl spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69517-613 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 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69517-613-17 1 in 1 CARTON 01/02/2018 1 15 mL in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/02/2018 Labeler - Healthlife of USA (079656178) Establishment Name Address ID/FEI Business Operations Kingston Pharmaceuticals 080386521 manufacture(69517-613)