Cvs Maximum Redness Relief 15 Ml (pld)

Cvs Maximum Redness Relief 15 Ml (pld)
SPL v3
SPL
SPL Set ID f70f9fc4-4022-336e-e053-6394a90a4d07
Route
OPHTHALMIC
Published
Effective Date 2023-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naphazoline (0.03 g) Glycerin (0.5 g)
Inactive Ingredients
Boric Acid Benzalkonium Chloride Edetic Acid Water Sodium Borate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-24

Description

Active ingredients Glycerin 0.5% Naphazoline hydrochloride 0.03%


Medication Information

Indications and Usage

Uses

• for the relief of redness of the eye due to minor eye irritations

• for the temporary relief of burning and irritation due to dryness of the eye

• for use as a protectant against further irritation or dryness of the eye

Dosage and Administration

Directions

instill 1 or 2 drops in the affected eye(s) up to 4 times daily.

Description

Active ingredients Glycerin 0.5% Naphazoline hydrochloride 0.03%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

• you experience eye pain

• you experience changes in vision

• you experience continued redness or irritation of the eye

• the condition worsens or persists for more than 72 hours

Section 50567-7

When using this product

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

• replace cap after using

• overuse may produce increased redness of the eye

• pupils may become enlarged temporarily

Section 50569-3

Ask a doctor before use if you have narrow angle glaucoma

Section 51727-6

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

Section 51945-4

Section 55105-1

Purposes

Glycerin....Lubricant

Naphazoline HCl....Redness Reliever

Section 60561-8

Other information

• store at room temperature

• remove contact lenses before using

Warnings

For external use only

Do Not Use

Do not use if solution changes color or becomes cloudy

Active Ingredients

Active ingredients

Glycerin 0.5%

Naphazoline hydrochloride 0.03%


Structured Label Content

Indications and Usage (34067-9)

Uses

• for the relief of redness of the eye due to minor eye irritations

• for the temporary relief of burning and irritation due to dryness of the eye

• for use as a protectant against further irritation or dryness of the eye

Dosage and Administration (34068-7)

Directions

instill 1 or 2 drops in the affected eye(s) up to 4 times daily.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• you experience eye pain

• you experience changes in vision

• you experience continued redness or irritation of the eye

• the condition worsens or persists for more than 72 hours

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 may produce increased redness of the eye

• pupils may become enlarged temporarily

Section 50569-3 (50569-3)

Ask a doctor before use if you have narrow angle glaucoma

Section 51727-6 (51727-6)

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purposes

Glycerin....Lubricant

Naphazoline HCl....Redness Reliever

Section 60561-8 (60561-8)

Other information

• store at room temperature

• remove contact lenses before using

Warnings

For external use only

Do Not Use (Do not use)

Do not use if solution changes color or becomes cloudy

Active Ingredients (Active ingredients)

Active ingredients

Glycerin 0.5%

Naphazoline hydrochloride 0.03%


Advanced Ingredient Data


Raw Label Data

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