Quality Choice Nasal Mist Extra Moisturizing Drug Facts

Quality Choice Nasal Mist Extra Moisturizing Drug Facts
SPL v1
SPL
SPL Set ID 460f0cc1-6a85-4d79-af87-a94fd151769e
Route
NASAL
Published
Effective Date 2025-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Benzalkonium Chloride Benzyl Alcohol Edetate Disodium Glycerin Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Polyethylene Glycol, Unspecified Povidone, Unspecified Water Sodium Phosphate, Dibasic, Unspecified Form Sodium Phosphate, Monobasic, Unspecified Form Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-02

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 Use:Shake well before use .Push down cup while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle rim between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Other Information
  • store at room temperature

TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING

Inactive Ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.

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 at 1-800-222-1222.

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Package/label Principal Display Panel

QUALITY CHOICE ®

NDC# 83324-211-01

*Compare to active ingredient in Afrin® No Drip Extra Moisturizing Pump Mist

No Drip

12 Hour Relief

Nasal Mist

Extra Moisturizing

Oxymetazoline HCl 0.05%

Nasal Solution

Fast, powerful Congestion Relief

For Colds & Allergies

Helps Rehydrate

Dry Nasal Passages

No Drip Pump Mist Won’t Drip from Nose or Down Throat

1 FL OZ (30mL)

100% QC SATISFACTION GURANTEED

IMPORTANT:Keep this carton for future reference on full labeling.

How to use:

Push down cup while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use.

Distributed by C.D.M.A., Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin ®No Drip Extra Moisturizing Pump Mist.


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 Use:Shake well before use .Push down cup while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle rim between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.

Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store at room temperature

TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, benzyl alcohol, edetate disodium, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.

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 at 1-800-222-1222.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Package/label Principal Display Panel (Package/Label Principal Display Panel)

QUALITY CHOICE ®

NDC# 83324-211-01

*Compare to active ingredient in Afrin® No Drip Extra Moisturizing Pump Mist

No Drip

12 Hour Relief

Nasal Mist

Extra Moisturizing

Oxymetazoline HCl 0.05%

Nasal Solution

Fast, powerful Congestion Relief

For Colds & Allergies

Helps Rehydrate

Dry Nasal Passages

No Drip Pump Mist Won’t Drip from Nose or Down Throat

1 FL OZ (30mL)

100% QC SATISFACTION GURANTEED

IMPORTANT:Keep this carton for future reference on full labeling.

How to use:

Push down cup while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use.

Distributed by C.D.M.A., Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin ®No Drip Extra Moisturizing Pump Mist.


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