Dg Health Maximum Strength Redness Relief (pld)

Dg Health Maximum Strength Redness Relief (pld)
SPL v5
SPL
SPL Set ID 9cb261ed-b708-1189-e053-2a95a90a547d
Route
OPHTHALMIC
Published
Effective Date 2021-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-31

Description

Active ingredients Glycerin 0.5% Naphazoline hydrochloride 0.03%


Medication Information

Warnings and Precautions

Warnings

For external use only

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 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 50570-1

Do not use if solution changes color or becomes cloudy

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 hydrochloride ----Redness reliever

Section 55106-9

Active ingredients

Glycerin 0.5%

Naphazoline hydrochloride 0.03%

Section 60561-8

Other information

  • store at room temperature
  • remove contact lenses before using
  • Tamper Evident: Do not use this product if imprinted neckband is missing or broken.

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.

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 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 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, edetate disodium, purified water, sodium borate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purposes

Glycerin ----Lubricant

Naphazoline hydrochloride ----Redness reliever

Section 55106-9 (55106-9)

Active ingredients

Glycerin 0.5%

Naphazoline hydrochloride 0.03%

Section 60561-8 (60561-8)

Other information

  • store at room temperature
  • remove contact lenses before using
  • Tamper Evident: Do not use this product if imprinted neckband is missing or broken.

Advanced Ingredient Data


Raw Label Data

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