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

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.
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

Other Information

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

Retain carton for future reference on full labeling





Inactive Ingredients

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

Description

0.05% Oxymetazoline Hydrochloride

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.

Box Label

Principle Display

Imag of Bottle

Active Ingredients

0.05% Oxymetazoline Hydrochloride

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

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.
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

Other Information

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

Retain carton for future reference on full labeling





Inactive Ingredients (Inactive ingredients)

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

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.

Box Label

Principle Display

Imag of Bottle

Active Ingredients

0.05% Oxymetazoline Hydrochloride

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:40.711466 · Updated: 2026-03-14T23:02:23.126471