LUBRICATING EYE DROPS- dextran 70 and hypromellose 2910 solution/ drops

Lubricating Eye Drops by

Drug Labeling and Warnings

Lubricating Eye Drops by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Velocity Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Dextran 70 0.1%: Lubricant
• Hypromellose 2910 0.3%: Lubricant

Uses

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

Warnings

For external use only

Do not use

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

When using this product

• to avoid contamination, do not touch tip of container to any surface
• replace cap after using

STOP USE

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

• 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

Inactive ingredients:

boric acid, calcium chloride, glycerin, glycine, magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium borate, sodium chloride, stabilized oxychoro complex, zinc chloride. May contain hydrocholric acid and/or sodium hydroxide to adjust pH.

Questions?

Call 1-800-645-2158

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUBRICATING EYE DROPS 
dextran 70 and hypromellose 2910 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1282
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
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 MPA.S) - UNII:RN3152OP35)	HYPROMELLOSE 2910 (4000 MPA.S)	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCINE (UNII: TE7660XO1C)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CHLORITE (UNII: G538EBV4VF)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1282-94	1 in 1 CARTON	01/22/2020
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 final	part349	01/22/2020

Labeler - Rugby Laboratories (079246066)

Registrant - Velocity Pharma LLC (962198409)

Establishment
Name	Address	ID/FEI	Business Operations
KILITCH HEALTHCARE INDIA LIMITED		650408037	manufacture(0536-1282)