Label: AFRIN SEVERE CONGESTION- oxymetazoline hydrochloride spray
- NDC Code(s): 11523-7020-1
- Packager: Bayer HealthCare LLC.
- 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 March 3, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
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
- 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 6 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?
- PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
INGREDIENTS AND APPEARANCE
AFRIN SEVERE CONGESTION
oxymetazoline hydrochloride spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7020 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) BENZYL ALCOHOL (UNII: LKG8494WBH) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) EDETATE DISODIUM (UNII: 7FLD91C86K) EUCALYPTOL (UNII: RV6J6604TK) MENTHOL (UNII: L7T10EIP3A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-7020-1 1 in 1 CARTON 08/31/2000 1 15 mL 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 08/31/2000 Labeler - Bayer HealthCare LLC. (112117283)