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NDC 65785-0169-04 PUR-WASH 929 g/946mL Details

PUR-WASH 929 g/946mL

PUR-WASH is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Niagara Pharmaceuticals Inc.. The primary component is WATER.

Product Information

NDC	65785-0169
Product ID	65785-169_bed9635f-79f8-9503-e053-2a95a90a013e
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	PUR-WASH
Proprietary Name Suffix	n/a
Non-Proprietary Name	Water
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	OPHTHALMIC
Active Ingredient Strength	929
Active Ingredient Units	g/946mL
Substance Name	WATER
Labeler Name	Niagara Pharmaceuticals Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA022305
Listing Certified Through	2024-12-31

Package

Package Images

NDC 65785-0169-04 (65785016904)

Pricing Information	N/A
NDC Package Code	65785-169-04
Billing NDC	65785016904
Package	118 mL in 1 BOTTLE, UNIT-DOSE (65785-169-04)
Marketing Start Date	2011-09-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL beda35c3-9a8b-47ad-e053-2995a90a7b1b Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Purified water 98.3%

Purpose

Eyewash

Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Warnings

For external use only

Do not use

if you experience any open wounds in or near the eyes and obtain immediate medical treatment
if solution changes color or becomes cloudy

When using this product

to avoid contamination, do not touch tip of container to any surface
do not reuse
once opened, discard

Stop use and ask a doctor if

side effects occur. You may report side effects to FDA at 1-800-FDA-1088
changes in vision
eye pain
condition worsens or persists
continued redness or irritation of the eye

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

Directions

snap off ridged tamper-evident tip
Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Other information

lot number is printed on the bottle
store at 20° to 25° C [68° to 77° F]
for your protection, this bottle has an imprinted white seal with black printing "TAMPER EVIDENT SEAL"
do not use if this seal is missing or broken
use before expiration date marked on bottle

Inactive ingredients

boric acid, sodium borate, sodium chloride

Questions ?

☎ Call 973-568-3361 9 a.m. to 5 p.m. EST Mon-Fri

SPL UNCLASSIFIED SECTION

Manufactured by:

Niagara Pharmaceuticals Inc.

60 Innovation Dr.

Dundas ON L9H 7P3

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Pur-Wash

Purified Water, 98.3%

Ophthalmic Solution

Eyewash

Single Use

Manufactured by:

Niagara Pharmaceuticals Inc.

60 Innovation Dr.

Dundas ON L9H 7P3

Made in Canada

Sterile Solution

4 Fl Oz [118 mL]

INGREDIENTS AND APPEARANCE

PUR-WASH

water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65785-169
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	929 g in 946 mL

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BORATE (UNII: 91MBZ8H3QO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65785-169-01	30 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	09/12/2011
2	NDC:65785-169-04	118 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	09/12/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA022305	09/12/2011

Labeler - Niagara Pharmaceuticals Inc. (205477792)

Name	Address	ID/FEI	Business Operations
Establishment
Niagara Pharmaceuticals Inc.		205477792	manufacture(65785-169)

Revised: 3/2021

Document Id: bed9635f-79f8-9503-e053-2a95a90a013e

Set id: beda35c3-9a8b-47ad-e053-2995a90a7b1b

Version: 1

Effective Time: 20210331

Search by Drug Name or NDC

NDC 65785-0169-04 PUR-WASH 929 g/946mL Details

PUR-WASH 929 g/946mL

Product Information

Package

Package Images

NDC 65785-0169-04 (65785016904)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL beda35c3-9a8b-47ad-e053-2995a90a7b1b Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Use

Warnings

Do not use

When using this product

Directions

Other information

Inactive ingredients

Questions ?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

INGREDIENTS AND APPEARANCE

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