SPL v1
SPL
SPL Set ID 3164dd41-cd3a-7149-e063-6294a90a81b8
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.

Do not share to avoid cross-contamination.

To avoid contamination, please use the product as soon as possible after opening

Indications and Usage

Relieves severe nasal congestion caused by colds, flu, or sinusitis.

Gently moisturizes and soothes nasal passages, providing additional moisture for dry nasal cavities.

Clears nasal passages and reduces swelling caused by sinus congestion.

Suitable for daily nasal hygiene for individuals with chronic nasal congestion or sinus issues.

Used for nasal irrigation in patients with chronic rhinitis, allergic rhinitis, nasal polyps, sinusitis, and other nasal conditions.

Ideal for post-surgical nasal care or nasal cleansing after chemotherapy, helping to clear nasal passages.

Dosage and Administration

Directions

1. Shake the bottle gently before use.

2. Adults & Children (6+ years): Spray 1-2 times per nostril, up to 6 times daily.

3. Infants & Young Children (under 6 years): Use 1 spray per nostril, up to 4 times daily, or as directed by a healthcare professional.

4. To apply, gently tilt head forward, insert nozzle into nostril, and press the pump while inhaling lightly.

5. Wipe the nozzle after use and close the cap securely.

6. 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

If irritation or discomfort occurs, stop use and consult a doctor

Section 50570-1

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

Not for use by individuals with large nasal cavity wounds.

Not for use by individuals with severe sodium chloride metabolic disorders or allergies.

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)

Relieves severe nasal congestion caused by colds, flu, or sinusitis.

Gently moisturizes and soothes nasal passages, providing additional moisture for dry nasal cavities.

Clears nasal passages and reduces swelling caused by sinus congestion.

Suitable for daily nasal hygiene for individuals with chronic nasal congestion or sinus issues.

Used for nasal irrigation in patients with chronic rhinitis, allergic rhinitis, nasal polyps, sinusitis, and other nasal conditions.

Ideal for post-surgical nasal care or nasal cleansing after chemotherapy, helping to clear nasal passages.

Dosage and Administration (34068-7)

Directions

1. Shake the bottle gently before use.

2. Adults & Children (6+ years): Spray 1-2 times per nostril, up to 6 times daily.

3. Infants & Young Children (under 6 years): Use 1 spray per nostril, up to 4 times daily, or as directed by a healthcare professional.

4. To apply, gently tilt head forward, insert nozzle into nostril, and press the pump while inhaling lightly.

5. Wipe the nozzle after use and close the cap securely.

6. 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.

Do not share to avoid cross-contamination.

To avoid contamination, please use the product as soon as possible after opening

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)

If irritation or discomfort occurs, stop use and consult a doctor

Section 50570-1 (50570-1)

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

Not for use by individuals with large nasal cavity wounds.

Not for use by individuals with severe sodium chloride metabolic disorders or allergies.

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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