RUGBY POLYVINYL ALCOHOL 1.4% LUBRICATING EYE DROPS- polyvinyl alcohol solution/ drops 
Rugby Laboratories

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Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15mL (PLD)

Active ingredient

Polyvinyl alcohol 1.4%

Purpose

Lubricant

Uses

Warnings

For external use only

Do not use this product if

  • solution changes color or becomes cloudy

When using this product

  • remove contact lenses before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed.

Stop use and ask a doctor if you experience

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

Keep out of the reach of children.

If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

Other information

Inactive ingredients

benzalkonium chloride, dibasic sodium phosphate hydrate, disodium edetate hydrate, monobasic sodium phosphate dihydrate, sodium chloride, water for injection.

Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15mL

Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15mL

RUGBY POLYVINYL ALCOHOL 1.4% LUBRICATING EYE DROPS 
polyvinyl alcohol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1408
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED1.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)  
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1408-941 in 1 BOX10/19/2023
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 DrugM01810/19/2023
Labeler - Rugby Laboratories (079246066)
Registrant - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
Hanlim Pharm. Co., LTD.687986034manufacture(0536-1408) , pack(0536-1408) , label(0536-1408)

Revised: 10/2023
Document Id: 081673b2-5c75-1200-e063-6394a90ae363
Set id: 081673b2-5c74-1200-e063-6394a90ae363
Version: 1
Effective Time: 20231019
 
Rugby Laboratories