Gentle Lubricant eye drops

Sterile Gentle Tears by

Drug Labeling and Warnings

Sterile Gentle Tears by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STERILE GENTLE TEARS LEADER- dextran 70, glycerin, hypromellose solution/ drops 
CARDINAL HEALTH

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Gentle Lubricant eye drops

• Active ingredients: Purpose
• Dextran 70 0.1%: Lubricant
• Glycerin 0.2%: Lubricant
• Hypromellose 0.3%: Lubricant

Uses

• temporary relief of burning and irritation due to dryness of the eye
• as a protectant against further irritation
• temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

Warnings

For external use only

Do not use

• if this solution changes color or becomes cloudy
• if you are sensitive to any ingredient in this product

When using this product

• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

Stop use and ask a doctor if you experience any of the following:

• you feel eye pain
• changes in vision
• continued redness or irritation of the eye
• condition worsens or persists for more than 72 hours

Keep out of reach of children.

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

Directions

• put 1 or 2 drops in the affected eye(s) as needed

Other Information

• store at room temperature
• discard 30 days

Inactive ingredients:

boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride. sodium borate, stabilized oxychloro complex

Questions?

1-855-314-1850

PRINCIPAL DISPLAY PANEL

STERILE GENTLE TEARS  LEADER
dextran 70, glycerin, hypromellose solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0588
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	1 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 mg  in 1 mL
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO)	HYPROMELLOSES	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
GLYCINE (UNII: TE7660XO1C)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC CHLORIDE (UNII: 86Q357L16B)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0588-1	1 in 1 CARTON	11/11/2021	10/25/2023
1		15 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	11/11/2021	10/25/2023

Labeler - CARDINAL HEALTH (063997360)

Revised: 1/2024

Document Id: 0fa82684-0906-5189-e063-6394a90aa7fc

34390-5

Set id: d08ab451-e8d5-28bb-e053-2995a90a4c03

Version: 5

Effective Time: 20240123