Rugby Lubricant Eye Drops 30ct and 50ct (PLD)

Rugby Lubricant Eye Drops by

Drug Labeling and Warnings

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

Drug Details [pdf]

RUGBY LUBRICANT EYE DROPS- carboxymethylcellulose sodium solution/ drops 
Rugby Laboratories

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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Rugby Lubricant Eye Drops 30ct and 50ct (PLD)

Active ingredient

Carboxymethylcellulose sodium 0.5%

Purpose

Lubricant

Uses

• for temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun
• may be used as a protectant against further irritation

Warnings

For external use only

Do not use this product if

• solution changes color or becomes cloudy

When using this product

• do not reuse
• once opened, discard
• to avoid contamination, do not touch tip of container to any surface
• do not touch unit-dose tip to eye

Stop use and ask a doctor if

• you experience eye pain
• changes in vision occur
• redness or irritation of the eye continues
• redness or irritation of the eye worsens or persists for more than 72 hours

Keep out of reach of children.

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

Directions

• to open, twist and pull tab to remove
• instill 1 or 2 drops in the affected eye(s) as needed and discard container
• if used for post-operative, (e.g., LASIK) dryness and discomfort, follow your eye doctor's instructions

Other information

• store at 15°-25°C (59°-77°F)
• use only if single-use container is intact
• use before expiration date marked on container
• RETAIN THIS CARTON FOR FUTURE REFERENCE

Inactive ingredients

calcium chloride, **hydrochloric acid, magnesium chloride, potassium chloride, purified water, sodium chloride, **sodium hydroxide, sodium lactate.

**May contain these ingredients to adjust pH.

Questions or comments?

Call 1-888-527-4276

Rugby Lubricant Eye Drops 30ct

Rugby Lubricant Eye Drops 50ct

RUGBY LUBRICANT EYE DROPS 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-5800
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
HYDROCHLORIC ACID (UNII: QTT17582CB)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
WATER (UNII: 059QF0KO0R)
SODIUM LACTATE (UNII: TU7HW0W0QT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-5800-30	30 in 1 BOX	03/23/2023	03/23/2023
1		0.4 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 0536-5800-50	50 in 1 BOX	03/23/2023	03/23/2023
2		0.4 mL in 1 BOTTLE, UNIT-DOSE; 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	03/23/2023	03/23/2023

Labeler - Rugby Laboratories (079246066)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	pack(0536-5800) , label(0536-5800)

Establishment
Name	Address	ID/FEI	Business Operations
Unimed Pharmaceuticals, Inc.		689852052	manufacture(0536-5800) , pack(0536-5800) , label(0536-5800)

Revised: 4/2023

Document Id: f9296a5a-0cd4-92d0-e053-6294a90acee9

34390-5

Set id: f7946ccb-5b09-cb62-e053-6294a90a012c

Version: 2

Effective Time: 20230412