SPL v2
SPL
SPL Set ID f4b8ff54-47b5-4d18-bf4e-b101abb22a24
Route
NASAL
Published
Effective Date 2025-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (50 mg)
Inactive Ingredients
Microcrystalline Cellulose Glycerin Polyethylene Glycol 1000 Edetate Disodium Sodium Phosphate, Monobasic Sodium Phosphate, Dibasic Benzyl Alcohol Benzalkonium Chloride Water Povidone Carboxymethylcellulose Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-01

Description

Active Ingredient Oxymetazoline Hydrochloride 0.05%

Purpose

Nasal Decongestant


Medication Information

Purpose

Nasal Decongestant

Description

Active Ingredient Oxymetazoline Hydrochloride 0.05%

Uses

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiroty allergies
  • temporarily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely
Directions
  • To use SHAKE WELL before use, Before using for the first time, remove the protective cap form the tip and prime the 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 nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
  • Wipe nozzle clean after use.
  • Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age consult a doctor.
Warnings 

Drug Facts 

Active Ingredient

Oxymetazoline Hydrochloride 0.05%

Other Information 
  • store between 20° and 25°C (68° to 77°F)
  • retain carton for future reference on full labeling
Inactive Ingredients 

Benzalkonium Chloride Solution, Benzyl Alcohol, Edetate Disodium, Flavor, Glycerin, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Polyethylene Glycol, Povidone, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic.

When Using This Product
  • Do not use more than directed
  • do not use for more than three 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.
Principal Display Panel 

CVS Health No Drip Nasal Mist

Extra Moisturizing Nasal Spray

Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 1.0 FLOZ (30ml)

Stop Use and Ask A Doctor If

symptoms persist.

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of the 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 diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.

Structured Label Content

Uses

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiroty allergies
  • temporarily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely
Purpose

Nasal Decongestant

Directions
  • To use SHAKE WELL before use, Before using for the first time, remove the protective cap form the tip and prime the 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 nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
  • Wipe nozzle clean after use.
  • Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age consult a doctor.
Warnings  (WARNINGS )

Drug Facts  (DRUG FACTS )

Active Ingredient

Oxymetazoline Hydrochloride 0.05%

Other Information  (Other information )
  • store between 20° and 25°C (68° to 77°F)
  • retain carton for future reference on full labeling
Inactive Ingredients  (Inactive ingredients )

Benzalkonium Chloride Solution, Benzyl Alcohol, Edetate Disodium, Flavor, Glycerin, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Polyethylene Glycol, Povidone, 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 three 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.
Principal Display Panel 

CVS Health No Drip Nasal Mist

Extra Moisturizing Nasal Spray

Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 1.0 FLOZ (30ml)

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 the Reach of Children (Keep out of the 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 diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.

Advanced Ingredient Data


Raw Label Data

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