FDA.reportPublic FDA data

Quality Choice Eye Drops Moisturizing Relief

Manufacturer
Chain Drug Marketing Association, Inc. | K.C. Pharmaceuticals, Inc.
Effective date
2023-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:17:14

Label at a glance#

ProductQuality Choice Eye Drops Moisturizing Relief
Active ingredientDEXTRAN 70, TETRAHYDROZOLINE HYDROCHLORIDE, POVIDONE, POLYETHYLENE GLYCOL 400
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Dextran 70......0.1%

Polyethylene glycol 400.....1%

Povidone.....1%

Tetrahydrozoline HCl.....0.05%

OTC - PURPOSE SECTION

Purpose

Dextran 70......Eye lubricant

Polyethylene glycol 400.....Eye lubricant

Povidone.....Eye lubricant

Tetrahydrozoline HCl.....Redness reliever

INDICATIONS & USAGE SECTION

Uses

  • relieves redness of the eye due to minor eye irritations
  • as a lubricant to prevent further irritation or to relieve dryness of the eye

WARNINGS SECTION

Warnings

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have narrow angle glaucoma

OTC - WHEN USING SECTION

When using this product

  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health proffessional before use.

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 four times daily.

OTHER SAFETY INFORMATION

Other information

store at 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-376-15ML - Milliliter63868-376e9daba6b-32b3-477d-95e6-66cbae61701512022-09-12

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-37663868-376-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
DEXTRAN 707SA290YK68ACTIB
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
POVIDONEFZ989GH94EACTIB
POLYETHYLENE GLYCOL 400B697894SGQACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM BORATE91MBZ8H3QOIACT

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
213579d8-f529-3c29-e063-6394a90a302e9b71c41d-8451-2fc6-e053-2995a90a57152024-08-26WarningsExact identifier
spl set id: 9b71c41d-8451-2fc6-e053-2995a90a5715

Reported adverse events (FAERS/openFDA)#

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