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

Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops by

Drug Labeling and Warnings

Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, KC Pharmaceuticals, Inc., Hanlim Pharm. Co., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Polyvinyl alcohol 1.4%

Purpose

Lubricant

Uses

• for use as a protectant against further irritation or to relieve dryness of the eye
• for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

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

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

Other information

• keep in a dry place
• store at 15°-25°C (59°-77°F)
• store away from sources of heat or ignition

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1408
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	1.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1408-94	1 in 1 BOX	10/19/2023
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 Drug	M018	10/19/2023

Labeler - Rugby Laboratories (079246066)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
Hanlim Pharm. Co., LTD.		687986034	manufacture(0536-1408) , pack(0536-1408) , label(0536-1408)