bion tears

Generic: dextran, hypromellose

Labeler: alcon laboratories, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name bion tears
Generic Name dextran, hypromellose
Labeler alcon laboratories, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dextran 70 1 mg/mL, hypromellose 2910 (4000 mpa.s) 3 mg/mL

Manufacturer
Alcon Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0065-0419
Product ID 0065-0419_34aa9128-4bc4-45a6-aeae-a8c1f7699183
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 1992-10-19

Pharmacologic Class

Established (EPC)
plasma volume expander [epc]
Mechanism of Action
osmotic activity [moa]
Physiologic Effect
increased intravascular volume [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00650419
Hyphenated Format 0065-0419

Supplemental Identifiers

RxCUI
309714 1088217
UNII
7SA290YK68 RN3152OP35
NUI
N0000184175 N0000009361 N0000010288

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bion tears (source: ndc)
Generic Name dextran, hypromellose (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
  • 3 mg/mL
source: ndc
Packaging
  • PRINCIPAL DISPLAY PANEL Severe Dry Eye Preservative-Free BION ® TEARS LUBRICANT EYE DROPS 28 Single-Use Vials 0.4 ml (0.015 FL OZ) Each STERILE Alcon DIRECTIONS (HOW TO USE) Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB. Do not pull off. Instill 1 or 2 drops in the affected eye(s) as needed. Throw away container. Do not reuse. Once opened, discard. All four containers within a pouch must be used within four days of opening the pouch. Tamper Evident: Containers are sealed in a protective foil pouch. Use only if foil pouch is undamaged at time of purchase. BION ® TEARS Lubricant Eye Drops is an advanced tear substitute especially formulated and packaged for persistent dry eye conditions requiring frequent therapy. MONEY BACK GUARANTEED To fully assess comfort, a 3 to 4-week trial of BION ® TEARS is recommended when switching from another brand of lubricant eye drops. If, however, you are not satisfied with the comfort BION ® TEARS provides, we ask that you send the unused portion of the product and the sales receipt, with a brief description of why you were dissatisfied, to QA/Consumer Affairs, Alcon Laboratories, Fort Worth, TX 76134-2099. You will receive a full refund within 6 to 8 weeks. U.S. Patent no. 5,403,598 © 2003, 2005, 2006, 2009, 2021 Alcon, Inc. Manufactured for: Alcon Alcon Laboratories, Inc. Fort Worth, TX 76134-0109 Made in France 419199 Lot: Exp.:
source: label

Packages (0)

No package records.

Ingredients (2)

dextran 70 (1 mg/mL) hypromellose 2910 (4000 mpa.s) (3 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "34aa9128-4bc4-45a6-aeae-a8c1f7699183", "openfda": {"nui": ["N0000184175", "N0000009361", "N0000010288"], "unii": ["7SA290YK68", "RN3152OP35"], "rxcui": ["309714", "1088217"], "spl_set_id": ["e48d82f0-2f18-e514-4caa-e397d6713b99"], "pharm_class_pe": ["Increased Intravascular Volume [PE]"], "pharm_class_epc": ["Plasma Volume Expander [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Alcon Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "BION TEARS", "product_id": "0065-0419_34aa9128-4bc4-45a6-aeae-a8c1f7699183", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Increased Intravascular Volume [PE]", "Osmotic Activity [MoA]", "Plasma Volume Expander [EPC]"], "product_ndc": "0065-0419", "generic_name": "Dextran, Hypromellose", "labeler_name": "Alcon Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "BION TEARS", "active_ingredients": [{"name": "DEXTRAN 70", "strength": "1 mg/mL"}, {"name": "HYPROMELLOSE 2910 (4000 MPA.S)", "strength": "3 mg/mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19921019", "listing_expiration_date": "20261231"}