FDA.reportPublic FDA data

DG Maximum Strength Redness Relief

Manufacturer
K.C. Pharmaceuticals, Inc.
Effective date
2022-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:44:33

Label at a glance#

ProductDG Maximum Strength Redness Relief
Active ingredientGLYCERIN, NAPHAZOLINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Glycerin 0.5%

Naphazoline hydrochloride 0.03%

OTC - PURPOSE SECTION

Purposes

Glycerin ----Lubricant

Naphazoline hydrochloride ----Redness reliever

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use if solution changes color or becomes cloudy

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have narrow angle glaucoma

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

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

OTHER SAFETY INFORMATION

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.

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55651-87055651-870-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
BORIC ACIDR57ZHV85D4IACT
SODIUM BORATE91MBZ8H3QOIACT
EDETATE DISODIUM7FLD91C86KIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
WATER059QF0KO0RIACT
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
efe45218-4dd7-1baa-e053-2995a90a004bd329be9c-9ea8-2306-e053-2995a90a77ee2022-12-15WarningsExact identifier
spl id: efe45218-4dd7-1baa-e053-2995a90a004b
spl set id: d329be9c-9ea8-2306-e053-2995a90a77ee

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.