Label: HYLATEARS- eye drops liquid
- NDC Code(s): 72094-001-01, 72094-001-02
- Packager: Hyalogic LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 10, 2022
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- ACTIVE INGREDIENT
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- DOSAGE & ADMINISTRATION
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- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PURPOSE
- HylaTears Updated Box
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INGREDIENTS AND APPEARANCE
HYLATEARS
eye drops liquidProduct 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:72094-001-02 1 in 1 BOX 02/12/2018 1 NDC:72094-001-01 20 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 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)
