SPL v1
SPL
SPL Set ID 31656d89-31d9-2329-e063-6294a90af9bc
Route
NASAL
Published
Effective Date 2025-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (3 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-28

Description

Sodium Chloride (NaCl) 3.0%


Medication Information

Warnings and Precautions

For nasal use only. Not for injections.

Indications and Usage

Helps relieve nasal congestion by reducing nasal swelling through osmotic action

Effectively clears thick mucus caused by colds, sinus infections, and allergies

Assists in post-surgical nasal recovery by reducing inflammation

Recommended for individuals with chronic sinusitis, rhinitis, or persistent congestion.

Dosage and Administration

Directions

1. Tilt your head slightly forward

2. Insert the nozzle into one nostril

3. Gently squeeze the bottle to release the solution

4. After application, gently blow your nose if necessary

5. Repeat in the other nostril

6. Use 2-6 times per day or as needed

7. Children and infants must be used under adult supervision. For children under 5 years old, please follow the advice of a healthcare professional

Description

Sodium Chloride (NaCl) 3.0%

Section 44425-7

1. Store at room temperature (15-30°C or 59-86°F).

2. Protect from extreme heat and direct sunlight.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and consult a doctor if irritation or infection occurs.

Section 50570-1

Do not use if the packaging is damaged or the solution appears cloudy.

Section 51727-6

Purified water USP

Section 51945-4

Section 55105-1

Reduces nasal congestion, clears mucus and allergens, and assists in relieving symptoms of chronic nasal congestion or sinusitis by drawing out excess fluid from swollen nasal tissues.

Section 55106-9

Sodium Chloride (NaCl) 3.0%


Structured Label Content

Indications and Usage (34067-9)

Helps relieve nasal congestion by reducing nasal swelling through osmotic action

Effectively clears thick mucus caused by colds, sinus infections, and allergies

Assists in post-surgical nasal recovery by reducing inflammation

Recommended for individuals with chronic sinusitis, rhinitis, or persistent congestion.

Dosage and Administration (34068-7)

Directions

1. Tilt your head slightly forward

2. Insert the nozzle into one nostril

3. Gently squeeze the bottle to release the solution

4. After application, gently blow your nose if necessary

5. Repeat in the other nostril

6. Use 2-6 times per day or as needed

7. Children and infants must be used under adult supervision. For children under 5 years old, please follow the advice of a healthcare professional

Warnings and Precautions (34071-1)

For nasal use only. Not for injections.

Section 44425-7 (44425-7)

1. Store at room temperature (15-30°C or 59-86°F).

2. Protect from extreme heat and direct sunlight.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and consult a doctor if irritation or infection occurs.

Section 50570-1 (50570-1)

Do not use if the packaging is damaged or the solution appears cloudy.

Section 51727-6 (51727-6)

Purified water USP

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Reduces nasal congestion, clears mucus and allergens, and assists in relieving symptoms of chronic nasal congestion or sinusitis by drawing out excess fluid from swollen nasal tissues.

Section 55106-9 (55106-9)

Sodium Chloride (NaCl) 3.0%


Advanced Ingredient Data


Raw Label Data

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