AFRIN ORIGINAL- oxymetazoline hydrochloride spray 
Bayer HealthCare LLC.

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.

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Afrin ®

Original

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

Warnings

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • diabetes
  • 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

Stop use and ask a doctor if symptoms persist

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other information

Inactive ingredients

benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Questions or comments?

Call 1-800-317-2165

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

Afrin ®

Oxymetazoline HCl Nasal Solution-Nasal Decongestant

Original

NASAL SPRAY

Fast, Powerful

Congestion

Relief

Colds • Allergies

up to 12

Hour

Relief

Maximum

Strength

#1 Doctor & Pharmacist

Recommended Brand

1/2 FL OZ (15 mL)

Product carton label

AFRIN  ORIGINAL
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-1167
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-1167-22 in 1 CARTON07/14/1975
121 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2NDC:11523-1167-31 in 1 CARTON07/14/1975
220 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3NDC:11523-1167-43 in 1 CARTON07/14/1975
330 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
4NDC:11523-1167-51 in 1 CARTON07/14/1975
430 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
5NDC:11523-1167-61 in 1 CARTON07/14/1975
515 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/14/1975
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 3/2021
Document Id: bca3c2cf-8029-133c-e053-2a95a90a6d29
Set id: 89c165ba-3ad5-49b5-a5bb-423dc8e15bad
Version: 6
Effective Time: 20210303
 
Bayer HealthCare LLC.