STYE- polyvinyl alcohol and povidone solution/ drops 
Medtech Products Inc.

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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Stye Eye Drops 63029-324

Drug Facts

Active ingredients

Polyvinyl alcohol 0.5%
Povidone 0.6%

Purpose

Lubricant
Lubricant

Uses

For temporary relief of discomfort due to minor irritations including: burning, stinging, itching.

Warnings

for external use only

Do not use

if solution changes color or becomes cloudy

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

instill 1 to 2 drops in the affected eye(s) as needed

Other information

Inactive ingredients

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

Questions?

1-800-344-7239

PRINCIPAL DISPLAY PANEL

Stye ™

LUBRICANT EYE DROPS

STERILE       0.5 fl oz (15 mL)

Stye ™
LUBRICANT EYE DROPS

STERILE	0.5 fl oz (15 mL)

STYE 
polyvinyl alcohol and povidone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-324
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED5 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
DEXTROSE (UNII: IY9XDZ35W2)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-324-151 in 1 BOTTLE12/01/2021
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34912/01/2021
Labeler - Medtech Products Inc. (122715688)

Revised: 10/2021
Document Id: c551b9d5-38e5-4582-af5d-34b9d223ee44
Set id: 60c11d3d-df20-4d1c-b425-49a84fecea30
Version: 1
Effective Time: 20211004
 
Medtech Products Inc.