ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution/ drops 
KC Pharmaceuticals, 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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Active ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

Purposes

Polyvinyl alcohol ......Lubricant

Povidone.....................Lubricant

Uses
• for use as a protectant against further irritation or to relieve dryness of the eye
• for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Warnings

For external use only

Do not use this product if

• solution changes color or becomes cloudy

When using this product
• remove contact lens before using
• to avoid contamination, do not touch tip of container to any surface
• replace cap after using. Keep container tightly closed.

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

Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

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

Other information

• store at 15°-30°C (59°-86°F)

Inactive ingredients

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

Carton

ARTIFICIAL TEARS 
polyvinyl alcohol, povidone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55651-008
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, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E) POVIDONE, UNSPECIFIED6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
DEXTROSE (UNII: IY9XDZ35W2)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55651-008-011 in 1 CARTON11/25/2003
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 finalpart34911/25/2003
Labeler - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
KC Pharmaceuticals, Inc.174450460manufacture(55651-008) , pack(55651-008) , label(55651-008)

Revised: 10/2019
Document Id: 94599912-bd08-4193-e053-2995a90a290d
Set id: eb6eb6c4-1609-407b-84e4-c7509811f3c0
Version: 2
Effective Time: 20191007
 
KC Pharmaceuticals, Inc.