Warnings
For external use only
Naphcon A
FDA Label NDC 52959-107
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H.j. Harkins Company, Inc. for the product Naphcon A (NDC 52959-107). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Do Not Use
- if you are sensitive to any ingredient in this product
- if this solution changes color or becomes cloudy
Otc - Ask Doctor
- narrow angle glaucoma
- heart disease
- high blood pressure
- trouble urinating
Otc - When Using
- pupils may become enlarged temporarily causing light sensitivity
- overuse may cause more eye redness
- remove contact lenses before using
- to avoid contamination, do not touch tip of container to any surface
- replace cap after each use
Otc - Stop Use
- you feel eye pain
- changes in vision occur
- redness or irritation of the eye(s) gets worse or lasts more than 72 hours
Otc - Keep Out Of Reach Of Children
- If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature.
Dosage & Administration
- adults and children 6 years and over: put 1 or 2 drops in the affected eye(s) up to 4 times daily
- children under 6 years: ask a doctor
Inactive Ingredient
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride, sodium hydroxide and/or hydrochloric acid
Indications & Usage
for the temporary relief of redness and itching of the eye(s) due to:
- ragweed
- pollen
- grass
- animal dander and hair
Otc - Purpose
- Redness Reliever and Antihistamine Eye Drops
- Relieves Itching & Redness
- EYE ALLERGY RELIEF
Otc - Active Ingredient
Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%
* Please review the disclaimer below.
