Rugby artificial tears solution/ drops

Otc - active ingredient section

Active ingredient Purpose

Polyvinyl Alcohol 1.4%...................................................Lubricant

Otc - purpose section

Uses

- relieves dryness of the eye

- prevents further irritation

Warnings section

Do not use

- if solution changes color or becomes cloudy

- with contact lenses

Otc - when using section

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

- replace cap after each use

Otc - ask doctor section

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

Otc - keep out of reach of children section

Keep out of reach of children

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

Indications & usage section

Directions

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

Storage and handling section

Other information

- store at 15 - 25C (59 - 77F)

- keep tightly closed

Inactive ingredient section

Inactive ingredients

benzalkonium chloride, dibasic sodium phosphate hydrate, edetate disodium hydrate, monobasic sodium phosphate dihydrate, purified water, sodium chloride

Dosage & administration section

Distributed by:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

Rugby Laboratories

Made in Korea

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-6354-01 15 ml bottle

Ingredients and appearance - Product information

Rugby artificial tears solution/ drops- Polyvinyl alcohol

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 68788-6354
Route of Administration Ophthalmic

Active Ingredient/Active Moiety

Ingredient Name Strength
Polyvinyl alcohol, unspecified ( UNII: 532B59J990)( Polyvinyl alcohol - UNII: 532B59J990 ) 14 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Benzalkonium chloride ( UNII: F5UM2KM3W7)
Sodium phosphate, dibasic, dodecahydrate ( UNII: E1W4N241FO)
Edetate disodium ( UNII: 7FLD91C86K)
Sodium phosphate, monobasic, dihydrate ( UNII: 5QWK665956)
Water ( UNII: 059QF0KO0R)
Sodium chloride ( UNII: 451W47IQ8X)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part349 USA

Labeler - Preferred Pharmaceuticals Inc.( 791119022)

Establishment

Name ID/FEI Business Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL( 68788-6354)

Package label.principal display panel