Xpect Eyewash — v4

Xpect Eyewash

3 Views

Version

v4

Effective date

September 30, 2025

Original packager

Yes

Sections captured

11

Identifiers

Document ID
edab0625-a706-405c-8952-041dab6a415b
Set ID
1d69365d-662b-4248-8fa9-1629451b549a
Application numbers
M018
Product NDCs
42961-231
Package NDCs
42961-231-01, 42961-231-02, 42961-231-03
Original packager NDCs
—

Names & Manufacturers

Brand names
Xpect Eyewash
Generic names
EYEWASH
Manufacturer names
Cintas Corporation
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
WATER
Routes
OPHTHALMIC
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
059QF0KO0R
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Purified water 98.4%
Dosage And Administration (1)

Sequence 1

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
Inactive Ingredient (1)

Sequence 1

Inactive ingredients boric acid, sodium borate, sodium chloride, sorbic acid
Indications And Usage (1)

Sequence 1

Uses For cleansing the eye to help relieve irritation by removing loose foreign material, air pollutants (smog or pollen), or chlorinated water.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (2)

Sequence 1

Principal Display Panel - 118mL Bottle EYEWASH 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). CAUTION: Tamper-evident cap. Do not use if twist-off top is broken or missing. 4 fl. oz. (118 mL) Xpect® First aid Bottle

Sequence 2

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
Purpose (1)

Sequence 1

Purpose Eyewash
Questions (1)

Sequence 1

Questions or comments? Call 1-877-973-2811 M-F 8 am-5 pm
Spl Product Data Elements (1)

Sequence 1

Xpect Eyewash Eyewash WATER WATER BORIC ACID SODIUM CHLORIDE SORBIC ACID SODIUM BORATE
Storage And Handling (1)

Sequence 1

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
Warnings (1)

Sequence 1

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

OpenFDA raw payload

{'application_number': ['M018'],
 'brand_name': ['Xpect Eyewash'],
 'generic_name': ['EYEWASH'],
 'is_original_packager': [True],
 'manufacturer_name': ['Cintas Corporation'],
 'package_ndc': ['42961-231-03', '42961-231-01', '42961-231-02'],
 'product_ndc': ['42961-231'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['OPHTHALMIC'],
 'spl_id': ['edab0625-a706-405c-8952-041dab6a415b'],
 'spl_set_id': ['1d69365d-662b-4248-8fa9-1629451b549a'],
 'substance_name': ['WATER'],
 'unii': ['059QF0KO0R']}