SPL v1
SPL
SPL Set ID 31639fa3-1ee0-be11-e063-6294a90a1c86
Route
NASAL
Published
Effective Date 2025-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (0.9 mg)
Inactive Ingredients
Water

Identifiers & Packaging

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

Sodium Chloride (NaCl) 0.9%

Medication Information

Warnings and Precautions

For nasal use only. Not for injections.

Indications and Usage

1. Gently cleanses the nasal passages and moisturizes nasal tissues.

2. Helps remove allergens, mucus, and airborne pollutants.

3. Suitable for daily nasal hygiene, allergy relief, and post-surgical care.

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) 0.9%

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

Hydrates, soothes, and clears nasal passages, relieves mild congestion, and flushes out allergens, dust, and pollutants, suitable for daily nasal hygiene for all ages.

Section 55106-9

Sodium Chloride (NaCl) 0.9%

Structured Label Content

Indications and Usage (34067-9)

1. Gently cleanses the nasal passages and moisturizes nasal tissues.

2. Helps remove allergens, mucus, and airborne pollutants.

3. Suitable for daily nasal hygiene, allergy relief, and post-surgical care.

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)

Hydrates, soothes, and clears nasal passages, relieves mild congestion, and flushes out allergens, dust, and pollutants, suitable for daily nasal hygiene for all ages.

Section 55106-9 (55106-9)

Sodium Chloride (NaCl) 0.9%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:49.520969 · Updated: 2026-03-14T23:08:10.789867