FDA.reportPublic FDA data

SilkTears

Manufacturer
SilkTears | Unither Manufacturing LLC
Effective date
2025-07-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:07:31

Label at a glance#

ProductSilkTears
Active ingredientGLYCERIN
Label structure8 sections

Dosage and administration

Instill 1 to 2 drops in the affected eye(s) as needed.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Lubricant

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Instill 1 to 2 drops in the affected eye(s) as needed.

WARNINGS SECTION

For external use only.

Do not use if solution changes color or becomes cloudy.

When using this product:
- do not touch tip of container to any surface to avoid contamination
- do not reuse
- once opened, discard

Stop use and ask a doctor if you experience:
- eye pain
- changes in vision
- continued redness or irritation

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

INACTIVE INGREDIENT SECTION

Inactive ingredients: dextrose, magnesium chloride, purified water, Silk-Derived Protein-4 (SDP-4), sodium acetate. May also contain hydrochloric acid and/or sodium hydroxide to adjust PH

INDICATIONS & USAGE SECTION

For the temporary relief of burning and irritation due to dryness of the eye.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Glycerin 0.2% – Lubricant

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 vials of 6 pouches each containing 5 sterile dispensers 0.01 FL OZ (0.35 mL EA)

SilkTears Principal Display PanelSilkTears Principal Display Panel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85837-0001-3SilkTears30 in 1 BOXSOLUTION/ DROPS304
85837-0001-3SilkTears0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.44

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85837-000185837-0001-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROSEIY9XDZ35W2IACT
GLYCERINPDC6A3C0OXACTIB
MAGNESIUM CHLORIDE02F3473H9OIACT
AMLISIMODK80BPM67OFIACT
SODIUM ACETATE4550K0SC9BIACT
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SilkTearsGLYCERIN OPHTHALMIC SOLUTIONSilkTears3866e2c1-051b-0b01-e063-6394a90af5cf2025-07-16WarningsExact identifier
ndc (package): 85837-0001-3
ndc (product): 85837-0001
ndc11 (package): 85837000103
spl id: 3a112f65-f676-a200-e063-6294a90a7ba4
spl set id: 3866e2c1-051b-0b01-e063-6394a90af5cf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.