ARTIFICAL TEARS- polyvinyl alcohol, and povidone solution/ drops 
medsource pharmaceuticals

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                                  Purpose

Polyvinyl alcohol 0.5%............................Lubricant

Povidone 0.6%......................................Lubricant

Uses

Warnings

For external use only.

Do not use

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 right away.

Directions

Inactive ingredients

benzlkonium chloride, dibasic sodium phosphate hydrate, edetate disodium, glucose, hydrochloric acid, monobasic sodium phosphate, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate hydrate, sodium hydroxide

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree, City, GA 30269

www.valuelabels.com

1-866-696-0957

Made in Korea

pdp

ARTIFICAL TEARS 
polyvinyl alcohol, and povidone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45865-744(NDC:50804-017)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL0.05 g  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE0.06 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45865-744-011 in 1 PACKAGE06/01/2018
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 finalpart34904/04/2016
Labeler - medsource pharmaceuticals (833685915)
Establishment
NameAddressID/FEIBusiness Operations
medsource pharmaceuticals833685915repack(45865-744)

Revised: 12/2018
Document Id: 7d77bb22-3b4b-867d-e053-2a91aa0aee65
Set id: 7d77bb0b-654d-904d-e053-2a91aa0a5543
Version: 2
Effective Time: 20181220
 
medsource pharmaceuticals