Label: CHILDREN AFRIN EXTRA MOISTURIZING STUFFY NOSE PUMP MIST STUFFY NOSE PUMP MIST- oxymetazoline hydrochloride spray, metered
- NDC Code(s): 11523-0091-1, 11523-0091-2
- 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 December 2, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Ask a doctor before use if you or a child has
- heart disease
- high blood pressure
- thyroid disease
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
Stop use and ask a doctor if symptoms persist
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- Keep out of reach of children.
- children 2 to under 6 years of age (with adult supervision): 2 or
3 sprays in each nostril not more often than every 10 to 12
hours. Use only recommended amount. Do not exceed 2
doses in any 24-hour period.
- children under 2 years of age: consult a doctor
To Use: 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 up to 10 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. Wipe nozzle clean after use. Secure cap after use.
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
INGREDIENTS AND APPEARANCE
CHILDREN AFRIN EXTRA MOISTURIZING STUFFY NOSE PUMP MIST STUFFY NOSE PUMP MIST
oxymetazoline hydrochloride spray, metered
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0091 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 0.025 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-0091-1 1 in 1 CARTON 07/14/2022 1 15 mL in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:11523-0091-2 2 in 1 CARTON 12/02/2022 2 15 mL in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/03/2022 Labeler - Bayer HealthCare LLC. (112117283)