STYE- polyvinyl alcohol and povidone solution/ drops

Stye by

Drug Labeling and Warnings

Stye by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

Stop use and ask a doctor if

• you experience eye pain
  
• you experience changes in vision
  
• you experience continued redness or irritation of the eye
  
• the condition worsens or persists for more than 72 hours

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

• store at room temperature 
  
• remove contact lenses before using

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)

INGREDIENTS AND APPEARANCE

STYE 
polyvinyl alcohol and povidone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-324
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	5 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-324-15	1 in 1 BOTTLE	12/01/2021
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 Drug	M018	12/01/2021

Labeler - Medtech Products Inc. (122715688)