HYDROPURE LUBRICATING EYE DROPS- glycerin solution/ drops

Hydropure Lubricating Eye Drops by

Drug Labeling and Warnings

Hydropure Lubricating Eye Drops by is a Otc medication manufactured, distributed, or labeled by OTE North America, Ote Pharma Sol B.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Glycerin 0.25%

Purpose

Eye Lubricant

INDICATIONS & USAGE

Uses

■ For the temporary relief of burning and irritation due to dryness of the eye ■ For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun ■ For use as a protectant against further irritation or to temporarily relieve dryness of the eye

WARNINGS

Warnings for External use only.

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

Do not use

Do not use ■ If solution changes color or becomes cloudy ■ If tamper evident ring is broken or missing.

When using this product

When using this product ■ Do not touch tip of container to any surface to avoid contamination

■ Replace cap after use.

Stop use and ask a doctor if

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, discontinue use and consult a doctor.

Directions

Directions

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

INACTIVE INGREDIENT

Inactive ingredients: borate, boric acid, sodium chloride, calcium chloride, l-carnitine, sodium hyaluronate

Other information

■ Store at 15 - 25 C (59-77 F).

Questions?

Questions?

Call + 1-800-203-9156

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROPURE LUBRICATING EYE DROPS 
glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84227-851
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LEVOCARNITINE (UNII: 0G389FZZ9M)
BORATE ION (UNII: 44OAE30D22)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84227-851-10	1 in 1 CARTON	05/15/2024
1		10 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 Drug	M018	05/15/2024

Labeler - OTE North America (963905034)

Establishment
Name	Address	ID/FEI	Business Operations
Ote Pharma Sol B.V.		418961173	manufacture(84227-851)