Label: AFRIN NO-DRIP ALLERGY SINUS- oxymetazoline hydrochloride spray, metered
- NDC Code(s): 11523-3220-1
- 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 May 13, 2021
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- ASK DOCTOR
When using this product
● do not use more than directed
● do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
● temporary discomfort may occur 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
· 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
Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered pump by depressing pump 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 rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
AFRIN NO-DRIP ALLERGY SINUS
oxymetazoline hydrochloride spray, metered
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-3220 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 1 mL Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) CAMPHOR, (-)- (UNII: 213N3S8275) EDETATE DISODIUM (UNII: 7FLD91C86K) EUCALYPTOL (UNII: RV6J6604TK) MENTHOL (UNII: L7T10EIP3A) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) POVIDONE (UNII: FZ989GH94E) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-3220-1 1 in 1 CARTON 08/30/2016 1 15 mL in 1 BOTTLE, PUMP; 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 08/30/2016 Labeler - Bayer HealthCare LLC (112117283)