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NDC 42961-0300-20 First Aid Direct Buffered Eyewash Sterile Isotonic 0.98 mL/mL Details

First Aid Direct Buffered Eyewash Sterile Isotonic 0.98 mL/mL

First Aid Direct Buffered Eyewash Sterile Isotonic is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Cintas Corporation. The primary component is WATER.

Product Information

NDC	42961-0300
Product ID	42961-300_0bc645f8-dc76-4264-a786-94863877ad4f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	First Aid Direct Buffered Eyewash Sterile Isotonic
Proprietary Name Suffix	n/a
Non-Proprietary Name	Water
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	OPHTHALMIC
Active Ingredient Strength	0.98
Active Ingredient Units	mL/mL
Substance Name	WATER
Labeler Name	Cintas Corporation
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2022-12-31

Package

Package Images

NDC 42961-0300-20 (42961030020)

Pricing Information	N/A
NDC Package Code	42961-300-20
Billing NDC	42961030020
Package	4 BOTTLE, UNIT-DOSE in 1 BOX, UNIT-DOSE (42961-300-20) / 30 mL in 1 BOTTLE, UNIT-DOSE
Marketing Start Date	2011-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bffcb462-a237-43c2-8505-97a61ff1cc4d Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Purified water, 98.525%

Purpose

eyewash

Uses

for irrigating the eye to help relieve irritation, discomfort, burning, stinging, smarting, or itching by removing loose foreign material, air pollutants (smog or pollen), or chlorinated water.

Warnings

to avoid contamination, do not touch tip of container to any surface, Do not reuse. Once opened, discard.
obtain immediate medical treatment for all open wounds in or near the eyes

Do not use

if solution changes color or becomes cloudy
with contact lenses
for injection

Stop use and ask a doctor if

you experience eye pain, changes in vision, continued redness, or irritation
condition worsens or persists

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

Directions

Twist top to remove.
Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

Inactive ingredients

benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

PRINCIPAL DISPLAY PANEL - 1 fl oz Bottle Label

Buffered

Eyewash

STERILE ISOTONIC

SOLUTION 1 fl oz

Principal Display Panel - 1 fl oz Bottle Label

INGREDIENTS AND APPEARANCE

FIRST AID DIRECT BUFFERED EYEWASH STERILE ISOTONIC

water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42961-300
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R)	Water	0.98 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Benzalkonium chloride (UNII: F5UM2KM3W7)
Edetate disodium (UNII: 7FLD91C86K)
Sodium chloride (UNII: 451W47IQ8X)
Sodium phosphate, Dibasic, Heptahydrate (UNII: 70WT22SF4B)
Sodium phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42961-300-20	4 in 1 BOX, UNIT-DOSE	10/01/2011
1		30 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part349	10/01/2011

Labeler - Cintas Corporation (056481716)

Registrant - Cintas Corporation (056481716)

Name	Address	ID/FEI	Business Operations
Establishment
Horizon Pharmaceuticals, Inc.		960418825	MANUFACTURE(42961-300) , STERILIZE(42961-300) , LABEL(42961-300) , PACK(42961-300) , ANALYSIS(42961-300)

Revised: 1/2021

Document Id: 0bc645f8-dc76-4264-a786-94863877ad4f

Set id: bffcb462-a237-43c2-8505-97a61ff1cc4d

Version: 3

Effective Time: 20210111