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NDC 65785-0166-02 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 | 65785-0166 |
|---|---|
| Product ID | 65785-166_777d4aa0-8bc7-7786-e053-2a91aa0a66cf |
| 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 65785-0166-02 (65785016602)
| NDC Package Code | 65785-166-02 |
|---|---|
| Billing NDC | 65785016602 |
| Package | 946 mL in 1 BOTTLE, UNIT-DOSE (65785-166-02) |
| Marketing Start Date | 2013-05-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7289103a-5cbf-42f4-8848-e827149a43ca Details
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
Directions
• pull cover off cap
• avoid contamination of rim and inside surfaces of the eyecup
• place eyecup surface to the affected eye, pressing tightly to prevent the escape of the liquid and tilt the head backward
• open eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash
Other information
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
INGREDIENTS AND APPEARANCE
| PUR-WASH
water solution |
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| Labeler - Niagara Pharmaceuticals Inc. (205477792) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Niagara Pharmaceuticals Inc. | 205477792 | manufacture(65785-166) | |
Revised: 10/2018
Document Id: 777d4aa0-8bc7-7786-e053-2a91aa0a66cf
Set id: 7289103a-5cbf-42f4-8848-e827149a43ca
Version: 2
Effective Time: 20181005