Optic Splash

Optic Splash
SPL v4
SPL
SPL Set ID e3d60c20-7cbc-4728-8e42-441b64608b88
Route
OPHTHALMIC
Published
Effective Date 2012-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naphazoline (20 mg) Glycerin (200 mg)
Inactive Ingredients
Boric Acid Camphor (synthetic) Benzalkonium Chloride Levomenthol Polysorbate 80 Potassium Chloride Sodium Borate Sodium Chloride Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-01-22

Description

Active ingredients Glycerin 0.2% Naphazoline hydrochloride 0.02%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

■ Relieves redness of the eye due to minor eye irritations.

■ Temporarily relieves burning and irritation due to dryness of the eye.

Dosage and Administration

Directions

Instill 1 to 2 drops in the affected eye(s) up to four times daily.

Description

Active ingredients Glycerin 0.2% Naphazoline hydrochloride 0.02%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product



■ to avoid contamination, do not touch tip of container to any surface



■ replace cap after using



■ overuse of this product may produce increased redness of the eye



■ pupils may become enlarged temporarily

Section 50569-3

A sk a doctor before use if you have



■ narrow angle glaucoma

Section 50570-1

Do not use



■ if solution changes color or becomes cloudy

Section 51727-6

Inactive ingredients

benzalkonium chloride, boric acid, camphor, menthol, polysorbate 80, potassium chloride, purified water, sodium borate, sodium chloride

Section 51945-4

opticsplashcart.jpg

Section 55105-1

Purpose

Glycerin     Lubricant

Naphazoline hydrochloride     Redness reliever

Section 55106-9

Active ingredients

Glycerin 0.2%

Naphazoline hydrochloride 0.02%

Section 60561-8

Other information

■ store tightly closed, protected from light.




Structured Label Content

Indications and Usage (34067-9)

Uses

■ Relieves redness of the eye due to minor eye irritations.

■ Temporarily relieves burning and irritation due to dryness of the eye.

Dosage and Administration (34068-7)

Directions

Instill 1 to 2 drops in the affected eye(s) up to four times daily.

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product



■ to avoid contamination, do not touch tip of container to any surface



■ replace cap after using



■ overuse of this product may produce increased redness of the eye



■ pupils may become enlarged temporarily

Section 50569-3 (50569-3)

A sk a doctor before use if you have



■ narrow angle glaucoma

Section 50570-1 (50570-1)

Do not use



■ if solution changes color or becomes cloudy

Section 51727-6 (51727-6)

Inactive ingredients

benzalkonium chloride, boric acid, camphor, menthol, polysorbate 80, potassium chloride, purified water, sodium borate, sodium chloride

Section 51945-4 (51945-4)

opticsplashcart.jpg

Section 55105-1 (55105-1)

Purpose

Glycerin     Lubricant

Naphazoline hydrochloride     Redness reliever

Section 55106-9 (55106-9)

Active ingredients

Glycerin 0.2%

Naphazoline hydrochloride 0.02%

Section 60561-8 (60561-8)

Other information

■ store tightly closed, protected from light.




Advanced Ingredient Data


Raw Label Data

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