RUGBY TETRAHYDROZOLINE OPHTHALMIC SOLUTION- tetrahydrozoline hcl solution/ drops

Rugby Tetrahydrozoline Ophthalmic Solution by

Drug Labeling and Warnings

Rugby Tetrahydrozoline Ophthalmic Solution by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, K.C. Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tetrahydrozoline HCI 0.05%

Purpose

Redness Reliever

Use

relieves redness in eye due to minor eye irritations

Warnings

For external use only

Warnings

Ask a doctor before use if you have narrow angle glaucoma

Warnings

When using this product

• pupils may become enlarged temporarily
• to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
• if solution changes color or becomes cloudy, do not use
• overuse may produce increased redness of the eye
• remove contact lens before using

Warnings

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

Warnings

If pregnant or breast-feeding, ask a professional before use.

Warnings

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.

Directions

instill 1 to 2 drops in the affected eye(s) up to 4 times daily

Other Information

store at 15°-30°C (59°-86°F)

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

Questions or Comments?

1-800-645-2158

Rugby Tetrahydrozoline Ophthalmic Solution

INGREDIENTS AND APPEARANCE

RUGBY TETRAHYDROZOLINE OPHTHALMIC SOLUTION 
tetrahydrozoline hcl solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1217
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BORIC ACID (UNII: R57ZHV85D4)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1217-94	1 in 1 BOX	06/08/2019
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	06/08/2019

Labeler - Rugby Laboratories (079246066)

Registrant - K.C. Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
K.C. Pharmaceuticals, Inc.		174450460	manufacture(0536-1217) , pack(0536-1217) , label(0536-1217)