MedPath

Xpect Eyewash

Xpect Eyewash

Approved
Approval ID

1d69365d-662b-4248-8fa9-1629451b549a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 30, 2025

Manufacturers
FDA

Cintas Corporation

DUNS: 056481716

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Eyewash

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42961-231
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
Eyewash
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 30, 2025
FDA Product Classification

INGREDIENTS (5)

WATERActive
Quantity: .984 mL in 1 mL
Code: 059QF0KO0R
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/30/2025

Principal Display Panel - 4 Count Box

EYEWASH

Active Ingredient:

Purified water 98.4%

Sterile

Single use only

For flushing the eye to help relieve irritation, burning, or itching by removing loose foreign material or air pollutants (smog or pollen).

Xpect® First aid

Distributed by: Cintas® • Mason, OH 45040 • www.cintas.com

NET WT PER BTL 1/2 FL OZ

4 Bottles per Box

Box

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/30/2025

Uses For cleansing the eye to help relieve irritation by removing loose foreign material, air pollutants (smog or pollen), or chlorinated water.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/30/2025

Active ingredient

Purified water 98.4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/30/2025

Purpose

Eyewash

WARNINGS SECTION

LOINC: 34071-1Updated: 9/30/2025

Warnings

For external use only

  • To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard
  • Remove contact lenses before using
  • If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor
  • Obtain immediate medical treatment for all open wounds in or near the eyes
  • If solution changes color or becomes cloudy do not use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/30/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/30/2025

Directions

  • Twist off top to open
  • Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle
  • Discard bottle after use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/30/2025

Other information

  • Store at 5°C to 29.4°C [41° to 85°F]
  • Do not use if top is broken or missing
  • Lot number and expiration date are embossed on bottle

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/30/2025

Inactive ingredients boric acid, sodium borate, sodium chloride, sorbic acid

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/30/2025

Questions or comments?

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