HYLATEARS- eye drops 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.

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Hyalogic Hyla Tears-corrected one of the inactive ingredients-added updated box under principle display panel.

active ingredient

Keep Out of reach of children

Directions

warnings

Inactive Ingredients

Uses

Purpose

HylaTears Updated Box

Final Box

HYLATEARS 
eye drops liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72094-001
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72094-001-021 in 1 BOX02/12/2018
1NDC:72094-001-0120 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/12/2018
Labeler - Hyalogic LLC (026884299)
Registrant - Regulatory Matters Consulting (080711165)

Revised: 2/2022
Document Id: d7ada5d1-e824-76e8-e053-2a95a90a6605
Set id: 64a30066-79a2-451d-e053-2991aa0ac68c
Version: 5
Effective Time: 20220210
 
Hyalogic LLC