RUGBY NATURES TEARS- dextran 70 and hypromellose 2910 solution/ drops
Rugby Laboratories, Inc.

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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Active ingredients Purpose

Dextran 70 0.1%..................................................Lubricant

Hypromellose 2910 0.3%.......................................Lubricant

Uses

- relieves dryness of the eye

- prevents further irritation

Warnings

Do not use

- if solution changes color or becomes cloudy

When using this product

- do not touch tip of container to any surface to avoid contamination

- replace cap after each use

- remove contact lenses before using

Stop use and ask a doctor

- if you experience 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

- instill 1 to 2 drops in the affected eye(s) as needed

Other information

- store at 15º - 25ºC (59º - 77ºF)

- keep tightly closed

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, potassium chloride, purified water, sodium borate, sodium chloride

Distributed by:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

Made in Korea

RUGBY NATURES TEARS
dextran 70 and hypromellose 2910 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1087
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-1087-94	1 in 1 CARTON	09/10/2015	10/31/2020
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	09/10/2015	10/31/2020

Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 1/2020

Document Id: 28a7b655-1fa6-41cf-b7a7-b07e55e84ee4

Set id: e9837779-7ffb-4ddd-b9e2-9a33c2010cf0

Version: 2

Effective Time: 20200129

Rugby Laboratories, Inc.