Afrin

Afrin
SPL v5
SPL
SPL Set ID 65bf1556-f234-9439-e053-2a91aa0a3194
Route
TOPICAL
Published
Effective Date 2018-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-04

Description

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Oxymetazoline hydrochloride 0.05%

Uses
  • temporarily relieves nasal congestion due to:
  • common cold 
  • hay fever
  • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely
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 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.

Drug Facts

questions

Call 1-800-317-2165, M-F 8am-5pm

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • retain card for future reference on full labeling
  • SAFETY SEALED: Do not use if "Afrin® Security Seal" imprinted on bottle is broken or missing
Package Labeling:

Active Ingredient 

Oxymetazoline hydrochloride 0.05%

Inactive Ingredients

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

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.

Ask A Doctor Before Use If You Have

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


Structured Label Content

Uses
  • temporarily relieves nasal congestion due to:
  • common cold 
  • hay fever
  • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely
Purpose

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 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.

Drug Facts

questions (Questions)

Call 1-800-317-2165, M-F 8am-5pm

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • retain card for future reference on full labeling
  • SAFETY SEALED: Do not use if "Afrin® Security Seal" imprinted on bottle is broken or missing
Package Labeling:

Active Ingredient  (Active ingredient )

Oxymetazoline hydrochloride 0.05%

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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 (Stop use and ask a doctor if)

symptoms persist

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)