SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT- dextran, polyethylene glycol 400, povidone, tetrahydrozoline solution/ drops 
Strategic Sourcing Services LLC

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Sunmark Eye Drops Advanced Moisturizer/Lubricant (PLD)

Active Ingredients

Dextran 70 0.1%
povidone 1%
Polyethylene glycol 400 1%
Tetrahydrozoline HCL 0.05%

Purpose

Eye Lubricant

Redness reliever

Uses

Warnings

For external use only

Ask a doctor before use if you have

narrow angle glucoma

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 become cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using

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

If pregnant or breast-feeding

ask a healthcare professional before use

Keep out of reach of children

If accidentally swallowed, get medical help or contact a Poison Control Center immediately

Directions

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

Other information

Store at 15 o- 30 oC (59 o- 86 oF)

Inactive Ingredients

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

Carton

SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT 
dextran, polyethylene glycol 400, povidone, tetrahydrozoline solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-697
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 700.1 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4001 g  in 100 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE1 g  in 100 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
BORIC ACID (UNII: R57ZHV85D4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-697-291 in 1 CARTON03/01/2007
115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01803/01/2007
Labeler - Strategic Sourcing Services LLC (116956644)
Registrant - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
KC Pharmaceuticals, Inc.174450460manufacture(49348-697) , pack(49348-697) , label(49348-697)

Revised: 12/2023
Document Id: 0d2942e7-fe3a-4dd4-e063-6394a90a020f
Set id: 0daa4e39-0447-44b6-a7d7-370b12bf9451
Version: 4
Effective Time: 20231223
 
Strategic Sourcing Services LLC