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

Rugby Polyvinyl Alcohol Lubricating Eye Drops by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

​Active ingredients

Polyvinyl alcohol 1.4%

PURPOSE

​Purpose

Polyvinyl alcohol: Lubricant

INDICATIONS & USAGE

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

Warnings

For external use only

• Do not use this product if solution changes color or becomes cloudy

When using this product

• remove contact lens 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.

DOSAGE & ADMINISTRATION

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

OTHER SAFETY INFORMATION

Other information

• Store at room temperature

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride (preservative), disodium edetate, purified water, sodium chloride, sodium phosphate dibasic, and sodium phosphate monobasic

QUESTIONS

Questions or comments?

call 1-800-645-2158

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RUGBY POLYVINYL ALCOHOL LUBRICATING EYE DROPS 
polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1218
Route of Administration	OPHTHALMIC

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

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1218-94	1 in 1 BOX	07/25/2019
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 final	part349	07/25/2019

Labeler - Rugby Laboratories (079246066)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(0536-1218) , label(0536-1218) , pack(0536-1218)