Original nasal Spray

Original nasal Spray
SPL v2
SPL
SPL Set ID 2ee2b332-9b85-45a6-b242-3f0ebfbd08a6
Route
NASAL
Published
Effective Date 2024-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sodium Phosphate, Monobasic Sodium Phosphate, Dibasic

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-01

Description

Oxymetazoline HCl 0.05%............. Nasal decongestant

Purpose

Oxymetazoline HCl 0.05%............. Nasal decongestant


Medication Information

Purpose

Oxymetazoline HCl 0.05%............. Nasal decongestant

Description

Oxymetazoline HCl 0.05%............. Nasal decongestant

Uses
  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
  • shrinks swollen nasal membranes so you can breathe more freely
Section 42229-5
  • Tamper Evident: Do not use the product if the temper evident seal is broken or missing.
  • This product is not manufactured or distributed by Bayer HealthCare LLC distributor of Afrin Original Nasal Spray.

Questions or comments?

1-800-935-2362, (Mon-Fri. 9 am-5 pm EST)

Distributed by C.D.M.A Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Question: 800-935-2362

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if symptoms persist.

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

Section 50569-3

Ask a doctor before use  if you have

  • heart disease 
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Section 50570-1

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
Section 55105-1

Nasal Decongestant

Directions
  • 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 10-12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor
  • Shake well before use.
  • to spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
Other Information
  • store between 20˚C to 25˚C (68˚F to 77˚F)
  • retain carton for future reference on full labeling
Inactive Ingredients

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

Principal Display Panel

NDC-63868- 607 -01

Active Ingredient                         purpose

Oxymetazoline HCl 0.05%............. Nasal decongestant


Structured Label Content

Uses
  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
  • shrinks swollen nasal membranes so you can breathe more freely
Section 42229-5 (42229-5)
  • Tamper Evident: Do not use the product if the temper evident seal is broken or missing.
  • This product is not manufactured or distributed by Bayer HealthCare LLC distributor of Afrin Original Nasal Spray.

Questions or comments?

1-800-935-2362, (Mon-Fri. 9 am-5 pm EST)

Distributed by C.D.M.A Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Question: 800-935-2362

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist.

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

Section 50569-3 (50569-3)

Ask a doctor before use  if you have

  • heart disease 
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Section 50570-1 (50570-1)

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
Section 55105-1 (55105-1)

Nasal Decongestant

Directions
  • 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 10-12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor
  • Shake well before use.
  • to spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
Other Information (Other information)
  • store between 20˚C to 25˚C (68˚F to 77˚F)
  • retain carton for future reference on full labeling
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC-63868- 607 -01

Active Ingredient                         purpose (Active Ingredient                         Purpose)

Oxymetazoline HCl 0.05%............. Nasal decongestant


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)