Rugby Artificial Tears by A-S Medication Solutions

Rugby Artificial Tears by

Drug Labeling and Warnings

Rugby Artificial Tears by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RUGBY ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops 
A-S Medication Solutions

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 ingredient                                                               Purpose

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

Uses

- relieves dryness of the eye

- prevents further irritation

Do not use

- if solution changes color or becomes cloudy

- with contact lenses

- 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 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 15° - 25°C (59° - 77°F)

- keep tightly closed

Inactive ingredients

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

Distributed by:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

Rugby Laboratories

Made in Korea

HOW SUPPLIED

Product: 50090-2283

Polyvinyl Alcohol

Label Image
RUGBY ARTIFICIAL TEARS 
polyvinyl alcohol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50090-2283(NDC: 0536-1084)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50090-2283-01 in 1 CARTON01/06/201612/31/2019
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/10/201512/31/2019
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-2283)

Revised: 1/2020
 
A-S Medication Solutions