Tetrahydrozoline Ophthalmic Solution by K.C. Pharmaceuticals, Inc.

Tetrahydrozoline Ophthalmic Solution by

Drug Labeling and Warnings

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

Drug Details [pdf]

TETRAHYDROZOLINE OPHTHALMIC SOLUTION- tetrahydrozoline hci solution/ drops 
K.C. Pharmaceuticals, Inc.

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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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

TETRAHYDROZOLINE OPHTHALMIC SOLUTION 
tetrahydrozoline hci solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55651-121
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
BORIC ACID (UNII: R57ZHV85D4)
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM BORATE (UNII: 91MBZ8H3QO)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55651-121-94	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 - K.C. Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
K.C. Pharmaceuticals, Inc.		174450460	manufacture(55651-121) , pack(55651-121) , label(55651-121)

Revised: 6/2019

Document Id: 8b52b564-3496-45a3-e053-2995a90a9c6e

34390-5

Set id: 8b52b564-3495-45a3-e053-2995a90a9c6e

Version: 1

Effective Time: 20190614