Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 99afe6a6-1350-49c6-9347-b7e531e35925
Route
NASAL
Published
Effective Date 2012-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (7.5 mg)
Inactive Ingredients
Benzalkonium Chloride Propylene Glycol Sodium Chloride Water Sodium Bicarbonate Glycerin Aloe Allantoin Hydrochloric Acid Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-07-15

Description

0.05% Oxymetazoline Hydrochloride


Medication Information

Description

0.05% Oxymetazoline Hydrochloride

Uses

Temporarily relieves nasal congestion due to common cold, sinus infections, hay fever, upper respiratory allergies.

Uses

temporarily relieves nasal congestion due to:

common cold

sinusitis

hay fever

upper respiratory allergies

Section 50570-1

Do not use this product for more than 3 consecutive days.



Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.

Warnings
  • Do not use this product for more than 3 consecutive days.Use only as directed.
  • Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.
  • Do not use this product if you have heart disease, high blood pressure, thyroid disease or diabetes unless directed by a doctor.
Box Label

Other Information

Store between 20 to 40 °C (68 to 104 °F)

Retain carton for future reference on full labeling





Principle Display

Imag of Bottle

Active Ingredients

0.05% Oxymetazoline Hydrochloride

Inactive Ingredients

Propylene glycol, glycerin, sodium chloride, hyaluronic acid, aloe vera, allantoin, sodium bicarbonate USP, benzalkonium chloride, edetate disodium, purified water

Directions for Dosing

    * Adults and children 6 to 12 years of age (with adult supervision): Per dose, 2 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: consult a doctor


Structured Label Content

Uses

Temporarily relieves nasal congestion due to common cold, sinus infections, hay fever, upper respiratory allergies.

Uses (uses)

temporarily relieves nasal congestion due to:

common cold

sinusitis

hay fever

upper respiratory allergies

Section 50570-1 (50570-1)

Do not use this product for more than 3 consecutive days.



Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.

Warnings
  • Do not use this product for more than 3 consecutive days.Use only as directed.
  • Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.
  • Do not use this product if you have heart disease, high blood pressure, thyroid disease or diabetes unless directed by a doctor.
Box Label

Other Information

Store between 20 to 40 °C (68 to 104 °F)

Retain carton for future reference on full labeling





Principle Display

Imag of Bottle

Active Ingredients

0.05% Oxymetazoline Hydrochloride

Inactive Ingredients (Inactive ingredients)

Propylene glycol, glycerin, sodium chloride, hyaluronic acid, aloe vera, allantoin, sodium bicarbonate USP, benzalkonium chloride, edetate disodium, purified water

Directions for Dosing

    * Adults and children 6 to 12 years of age (with adult supervision): Per dose, 2 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: consult a doctor


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)