HylaTears: Package Insert and Label Information

HYLATEARS- hypromellose 2910 (4000 mpa.s) liquid
Hyalogic LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

active ingredient

Keep Out of reach of children

Directions

warnings

Inactive Ingredients

Uses

Purpose

HylaTears Updated Box

Final Box
(click image for full-size original)

HYLATEARS
eye drops liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72094-001
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYPROMELLOSE 2910 (4000 MPA.S) (HYPROMELLOSE 2910 (4000 MPA.S)) HYPROMELLOSE 2910 (4000 MPA.S) 3 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE
HYALURONATE SODIUM
POTASSIUM CHLORIDE
SODIUM PHOSPHATE DIBASIC DIHYDRATE
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72094-001-02 1 BOTTLE, DROPPER in 1 BOX contains a BOTTLE, DROPPER (72094-001-01)
1 NDC:72094-001-01 20 mL in 1 BOTTLE, DROPPER This package is contained within the BOX (72094-001-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 02/12/2018
Labeler — Hyalogic LLC (026884299)
Registrant — Regulatory Matters Consulting (080711165)

Revised: 02/2022 Hyalogic LLC

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