SOUND BODY ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution/ drops 
United Exchange Corp.

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: if this solution changes color or becoems cloudy or if you are sensitive to any ingredient in this product

When using this product

Stop use and ask a doctor if you feel eye pain

If pregnant or breast-feeding, ask a health professional before use

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients: benzalkonium chloride, boric acid, edetate disodium, potassium chloride, purified water, sodium borate, and sodium chloride

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

image description

SOUND BODY ARTIFICIAL TEARS 
polyvinyl alcohol, povidone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-565
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL5 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-565-151 in 1 BOX
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/25/2014
Labeler - United Exchange Corp. (840130579)

Revised: 2/2014
Document Id: 256a32b9-d8bb-468f-8822-4862fd60f05c
Set id: 558203ec-a280-4643-b7ed-5e8416ad13a3
Version: 1
Effective Time: 20140225
 
United Exchange Corp.