HYLATEARS- eye drops liquid

HylaTears by

Drug Labeling and Warnings

HylaTears by is a Otc medication manufactured, distributed, or labeled by Hyalogic LLC, Optikem International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Principal display panel

Directions

Instill one or two drops in the affected eye(s) as needed.

Purpose: Lubricant

Keep out of Reach

Keep out of reach of children

For external use only.

If you are pregnant, nursing, trying to conceive, taking any medications, or have a medical condition, please consult your healthcare practitioner before using this product.

Stop use and ask a doctor if: You experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Do not use if solution changes color or becomes cloudy.

If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

Inactive Ingredients:
Water, sodium chloride, sodium hyaluron-ate, potassium chloride, sodium phosphate dibasic, sodium phosphate monobasic, benzyl alcohol.

Hypromellose 0.3% Lubricant

Inidication and Use

For the temporary relief of burning, irritaiton and discomofrt due to drynes of the eye or exposure to wind and sun,. May be uysed as a protectant against further irritation

INGREDIENTS AND APPEARANCE

HYLATEARS 
eye drops liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72094-001
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 MPA.S) - UNII:RN3152OP35)	HYPROMELLOSE 2910 (4000 MPA.S)	3 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72094-001-03	20 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M014	02/12/2018

Labeler - Hyalogic LLC (026884299)

Establishment
Name	Address	ID/FEI	Business Operations
Optikem International, Inc.		092765312	manufacture(72094-001)