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Sunmark Eye Drops Original Formula

Medically reviewed on Mar 20, 2017

Dosage form: liquid
Ingredients: TETRAHYDROZOLINE HYDROCHLORIDE 0.05g in 100mL
Labeler: McKesson Corporation
NDC Code: 49348-037

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.

Drug Facts

Active Ingredient

Tetrahydrozoline HCL 0.05%

Purpose

Redness reliever

Uses
  • relieves redness of the eye due to minor eye irritations

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

SUNMARK EYE DROPS ORIGINAL FORMULA 
tetrahydrozoline hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-037
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BORIC ACID 
EDETATE DISODIUM 
WATER 
SODIUM BORATE 
SODIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:49348-037-291 BOTTLE, PLASTIC in 1 CARTON
115 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/01/2007
Labeler - McKesson Corporation (177667227)
Registrant - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIOperations
KC Pharmaceuticals, Inc.174450460manufacture(49348-037), pack(49348-037), label(49348-037)

 
McKesson Corporation

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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