SK Health Advanced Relief

SK Advanced Relief Eye Drops by

Drug Labeling and Warnings

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

Drug Details [pdf]

SK ADVANCED RELIEF EYE DROPS- dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution 
Synpac-Kingdom Pharmaceutical, 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 Health Advanced Relief

Active ingredients

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

Purposes

Dextran 70.....................................Lubricant

Polyethylene glycol 400....................Lubricant

Povidone........................................Lubricant

Tetrahydrozoline HCl................Redness reliever

Uses

• for the relief of redness of the eye due to minor eye irritations
• as a lubricant to prevent further irritation or to relieve dryness of the eye

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
• continued 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

Principal Display Panel

SK ADVANCED RELIEF EYE DROPS 
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81772-005
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	0.1 g  in 100 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	1 g  in 100 mL
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E)	POVIDONE, UNSPECIFIED	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81772-005-01	1 in 1 CARTON	06/24/2021	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	06/24/2021	12/31/2021

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

Registrant - Synpac-Kingdom (657636332)

Establishment
Name	Address	ID/FEI	Business Operations
Synpac-Kingdom		657636332	manufacture(81772-005) , pack(81772-005) , label(81772-005)

Revised: 11/2022

Document Id: a12f8b1b-c370-40f2-ba1f-bbf797fd9d21

34390-5

Set id: d78e2023-700d-42fe-acca-022435f4a380

Version: 3

Effective Time: 20221123