SK Dry Eye Relief by Synpac-Kingdom Pharmaceutical, Co., Ltd. / Synpac-Kingdom SK Dry Eye Relief

SK Dry Eye Relief by

Drug Labeling and Warnings

SK Dry Eye Relief 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 DRY EYE RELIEF- glycerin, hypromellose, polypropylene glycol 400 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 Dry Eye Relief

Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 400 1%

Purpose

Glycerin..........................Lubricant

Hypromellose..................Lubricant

Polyethylene glycol 400....Lubricant

Uses

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

Warnings

For external use only

Do not use this product if solution changes color or becomes cloudy

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

When using this product

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

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 healh professional before use.

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed.
• Children under 6 years of age: ask a doctor.

Other information

• Store at room temperature
• Remove contact lens before using

Inactive ingredients

dextrose, sodium chloride, potassium chloride, sodium phosphate monobasic, sodium phosphate dibasic, sodium bicarbonate, sodium citrate, edetate disodium, benzalkonium chloride, and purified water.

Principal Display Panel

SK Dry Eye Relief Eye Drops

0.5 FL OZ (15 mL)

SK DRY EYE RELIEF 
glycerin, hypromellose, polypropylene glycol 400 solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81772-004
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.2 g  in 100 mL
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO)	HYPROMELLOSE, UNSPECIFIED	0.2 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81772-004-01	1 in 1 CARTON	06/29/2021	07/19/2021
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	07/19/2021

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

Registrant - Synpac-Kingdom (657636332)

Establishment
Name	Address	ID/FEI	Business Operations
Synpac-Kingdom		657636332	manufacture(81772-004) , pack(81772-004) , label(81772-004)

Revised: 7/2021

Document Id: 935a2184-6a4b-4125-8ef6-51412c86e0c3

34390-5

Set id: e46120fc-e4ed-4f66-9a00-09299ccaaec8

Version: 2

Effective Time: 20210715