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NDC 42126-6100-01 OASIS Tears 0.22 g/100mL Details
OASIS Tears 0.22 g/100mL
OASIS Tears is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by OASIS Medical, Inc.. The primary component is GLYCERIN.
Product Information
NDC | 42126-6100 |
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Product ID | 42126-6100_1ef317c1-aad4-4b95-ac9e-14fde3028135 |
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 | OASIS Tears |
Proprietary Name Suffix | Preservative-Free Lubricant Eye |
Non-Proprietary Name | Glycerin |
Product Type | HUMAN OTC DRUG |
Dosage Form | SOLUTION/ DROPS |
Route | OPHTHALMIC |
Active Ingredient Strength | 0.22 |
Active Ingredient Units | g/100mL |
Substance Name | GLYCERIN |
Labeler Name | OASIS Medical, Inc. |
Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part349 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 42126-6100-01 (42126610001)
NDC Package Code | 42126-6100-1 |
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Billing NDC | 42126610001 |
Package | 3 POUCH in 1 CARTON (42126-6100-1) / 10 VIAL, SINGLE-USE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-USE |
Marketing Start Date | 2017-11-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d9d71b1d-82a6-42e7-9ef2-2d041daef936 Details
Uses
- for the temporary relief of burning and irritation due to dryness of the eye.
- for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.
- for use as a protectant against further irritation or to relieve dryness of the eye.
- for use as a lubricant to prevent further irritation or to relieve dryness of the eye.
Warnings
For external use only
Do not use
- if solution changes color or becomes cloudy.
- if you are sensitive to any ingredient in this product.
When using this product
- to avoid contamination do not touch tip of container to any surface.
- once opened, discard
- do not reuse
Questions, or to report an adverse event call
Other Information
Inactive Ingredients
PRINCIPAL DISPLAY PANEL - 0.3 mL Pouch Carton
INGREDIENTS AND APPEARANCE
OASIS TEARS
PRESERVATIVE-FREE LUBRICANT EYE
glycerin solution/ drops |
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Labeler - OASIS Medical, Inc. (194121018) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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LABORATOIRE UNITHER COUTANCES | 574139809 | MANUFACTURE(42126-6100) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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UNITHER MANUFACTURING LLC | 079176615 | MANUFACTURE(42126-6100) |
Revised: 4/2021
Document Id: 1ef317c1-aad4-4b95-ac9e-14fde3028135
Set id: d9d71b1d-82a6-42e7-9ef2-2d041daef936
Version: 3
Effective Time: 20210421