Drug Labeling and Warnings

Drug Details [pdf]

ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution/ drops 
Strategic Sourcing Services LLC

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%

Purpose

Polyvinyl alcohol - Eye lubricant

Povidone - Eye lubricant

Keep out of reach of children

If accidental ly swallowed, get medical help or contact a Poison Control Center immediately.

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

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed.
  • 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

Directions

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

Inactive ingredients

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

Other information

Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
RETAIN THIS CARTON FOR FUTURE REFERENCE
Store at 15o - 30oC (59o - 86oF)

Carton

ARTIFICIAL TEARS 
polyvinyl alcohol, povidone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62011-0101
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE6 mg  in 1 mL
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62011-0101-11 in 1 CARTON03/01/201212/31/2015
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 finalpart34903/01/201212/31/2015
Labeler - Strategic Sourcing Services LLC (116956644)
Registrant - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
KC Pharmaceutical, Inc.174450460manufacture(62011-0101) , pack(62011-0101) , label(62011-0101)

Revised: 10/2019
 
Strategic Sourcing Services LLC