SK Original Eye Drops by Synpac-Kingdom Pharmaceuticals, Co., Ltd. SK Original Eye Drops

SK Original Eye Drops by

Drug Labeling and Warnings

SK Original Eye Drops by is a Otc medication manufactured, distributed, or labeled by Synpac-Kingdom Pharmaceuticals, Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SK ORIGINAL EYE DROPS- tetrahydrozoline hcl solution 
Synpac-Kingdom Pharmaceuticals, Co., Ltd.

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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SK Original Eye Drops

Active ingredient

Tetrahydrozoline HCl 0.05%

Purpose

Tetrahydrozoline HCl......Redness reliever

Use

• for the relief of redness of the eye due to minor eye irritations

Warnings

For external use only

Do not use if solution changes color or becomes cloudy

Ask a doctor before use if you have narrow angle glaucoma

When using this product

• pupils may become enlarged temporarily
• do not touch tip of container to any surface to avoid contamination
• replace cap after using
• overuse may produce increased redness of the eye

Stop use and ask a doctor if you experience

• eye pain
• changes in vision
• coontinued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Directions

Instill 1 or 2 drops in the affected eye(s) up to four times daily.

Other information

• Store at room temperature
• Remove contact lens before using

Inactive ingredients

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

SK ORIGINAL EYE DROPS 
tetrahydrozoline hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81772-001
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
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BORATE (UNII: 91MBZ8H3QO)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81772-001-01	1 in 1 CARTON	06/29/2021	12/31/2021
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	06/29/2021	12/31/2021

Labeler - Synpac-Kingdom Pharmaceuticals, Co., Ltd. (657636332)

Registrant - Synpac-Kingdom Pharmaceuticals, Co., Ltd. (657636332)

Establishment
Name	Address	ID/FEI	Business Operations
Synpac-Kingdom Pharmaceuticals, Co., Ltd.		657636332	pack(81772-001) , manufacture(81772-001)

Revised: 10/2022

Document Id: 41e8d38d-f4be-47a4-9262-401ba6573594

34390-5

Set id: bb69ccea-0010-43d6-99e1-28370a77751d

Version: 2

Effective Time: 20221031

 

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