SILKTEARS- glycerin ophthalmic solution solution/ drops

SilkTears by

Drug Labeling and Warnings

SilkTears by is a Otc medication manufactured, distributed, or labeled by SilkTears, Unither Manufacturing LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Lubricant

Dosage and Administration

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

WARNINGS

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

Inactive ingredients: purified water, Silk-Derived Protein-4 (SDP-4), sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic.

INDICATIONS & USAGE

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

KEEP OUT OF REACH OF CHILDREN

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

ACTIVE INGREDIENT

Glycerin 0.4% – Lubricant

PRINCIPAL DISPLAY PANEL

SilkTears 0.4 mL carton (30-count single-use vials)

INGREDIENTS AND APPEARANCE

SILKTEARS 
glycerin ophthalmic solution solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85837-0001
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 mg  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
AMLISIMOD (UNII: K80BPM67OF)	10 mg  in 1000 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85837-0001-3	30 in 1 BOX	06/25/2025
1		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	06/25/2025

Labeler - SilkTears (119521895)

Registrant - SilkTears (119521895)

Establishment
Name	Address	ID/FEI	Business Operations
Unither Manufacturing LLC		079176615	manufacture(85837-0001)