SUNMARK EYE DROPS ORIGINAL FORMULA- tetrahydrozoline hcl solution/ drops 
Strategic Sourcing Services LLC

----------

Sunmark Eye Drops Original Formula (PLD)

Active Ingredient

Tetrahydrozoline HCL 0.05%

Purpose

Redness reliever

Uses

Warnings

For external use only

Ask a doctor before use if you have

narrow angle glaucoma

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 becomes 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 health professional before use

Keep out of reach of chlidren

If swallowed, get medical help or contact a Poison Control Center right away

Directions

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

Other information

Store at 15 -30°C (59°-86°F)

Inactive ingredients

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

CARTON

SUNMARK EYE DROPS ORIGINAL FORMULA 
tetrahydrozoline hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-037
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-037-291 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(49348-037) , pack(49348-037) , label(49348-037)

Revised: 12/2023
Document Id: 0d295927-09c8-5b68-e063-6394a90a965f
Set id: 33efa7e9-4c3a-4d72-af31-c5e35095c2ff
Version: 5
Effective Time: 20231223
 
Strategic Sourcing Services LLC