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

SK Lubricant Eye Drops by

Drug Labeling and Warnings

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

Drug Details [pdf]

SK LUBRICANT EYE DROPS- polyethylene glycol 400, propylene glycol 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 Lubricant Eye Drops

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Active ingredients

Polyethylene glycol 400.....Lubricant

Propylene glycol...............Lubricant

Use

• for the temporary relief of burning and irritation due to dryness of the eye

Warnngs

For external use only

Do not use

• if this product changes color or becomes cloudy
• if you are sensitive to any ingredient in this product

When using this product

• do not touch the tip of container to any surface to avoid contamination
• replace cap after using

Stop use and ask a doctor if you experience

• eye pain
• changes in vision occur
• 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) as needed.

Other information

• Store at room temperature

Inactive ingredients

Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, and zinc chloride

Principle Display Panel

SK LUBRICANT EYE DROPS 
polyethylene glycol 400, propylene glycol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81772-003
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	3 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SODIUM BORATE (UNII: 91MBZ8H3QO)
BORIC ACID (UNII: R57ZHV85D4)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
ZINC CHLORIDE (UNII: 86Q357L16B)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81772-003-01	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 (657636332)

Establishment
Name	Address	ID/FEI	Business Operations
Synpac-Kingdom		657636332	manufacture(81772-003) , pack(81772-003) , label(81772-003)

Revised: 10/2022

Document Id: c996e410-6b94-45f8-a32b-488026520d68

34390-5

Set id: d4b95726-8ecf-433c-8cf6-a458c1518070

Version: 2

Effective Time: 20221031

 

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