drug facts

drug facts
SPL v33025
SPL
SPL Set ID e7aedab9-da4c-4494-a896-1e6ed2a956fe
Route
nasal
Published
Effective Date 2025-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
naphazoline (1 mg)
Inactive Ingredients
boric acid sodium borate edetate disodium thimerosal water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-07-15
Description

Naphazoline Hydrochloride: 0.05% Purposes: Nasal Decongestant

Medication Information

Description

Naphazoline Hydrochloride: 0.05% Purposes: Nasal Decongestant

Uses:

For the temporary relief of nasal congestion due to the common cold.

Packaging

Directions:

1 or 2 drops in each nostril not more often than every 6 hours. 

Do not give to children under 12 years of age unless directed by a doctor. 

Active Ingredients

Naphazoline Hydrochloride: 0.05%

Purposes: Nasal Decongestant

Other Information: 

Do not use if safety seal on bottle or dropper tip is loose, broken or missing. Store in a cool dry place. 

Inactive Ingredients:

Boric Acid, Sodium Borate, Disodium Edetate, Thimerosal, Purified Water

Do Not Use This Product

- for more than 3 days. Use only as directed. Frequent or prolonged use may cuase nasal congestion to recur or worsen. If symptons persist, consult a doctor.

- If you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

- in children under 12 years of age because it may cause sedation if swallowed.

Keep Out of Reach of Children

If swallowed, get medical help, or contact a Poison Control Center immediately.

If Pregnant Or Breast Feeding,

ask a health professional before use. 

Warnings: Do Not Exceed Recommended Dosage.

This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. 

The use of this container by more than one person may spread infection.

Structured Label Content

Uses:

For the temporary relief of nasal congestion due to the common cold.

Packaging

Directions:

1 or 2 drops in each nostril not more often than every 6 hours. 

Do not give to children under 12 years of age unless directed by a doctor. 

Active Ingredients

Naphazoline Hydrochloride: 0.05%

Purposes: Nasal Decongestant

Other Information:  (Other information: )

Do not use if safety seal on bottle or dropper tip is loose, broken or missing. Store in a cool dry place. 

Inactive Ingredients:

Boric Acid, Sodium Borate, Disodium Edetate, Thimerosal, Purified Water

Do Not Use This Product (Do not use this product)

- for more than 3 days. Use only as directed. Frequent or prolonged use may cuase nasal congestion to recur or worsen. If symptons persist, consult a doctor.

- If you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

- in children under 12 years of age because it may cause sedation if swallowed.

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

If swallowed, get medical help, or contact a Poison Control Center immediately.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use. 

Warnings: Do Not Exceed Recommended Dosage. (Warnings: Do not exceed recommended dosage.)

This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. 

The use of this container by more than one person may spread infection.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:55.700153 · Updated: 2026-03-14T23:11:56.566307