SOUND BODY ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution/ drops

Sound Body Artificial Tears by

Drug Labeling and Warnings

Sound Body Artificial Tears by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                              Purpose

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

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

PURPOSE

Uses

• relieves dryness of the eye(s)
• temporarily relieves burning and irritations due to dryness of the eye
• protects against further irritation

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use: if this solution changes color or becoems cloudy or if you are sensitive to any ingredient in this product

WHEN USING

When using this product

• remove contact lenses before using
• to avoid contamination, do not touch tip of container to any surface
• replace cap after each use

ASK DOCTOR

Stop use and ask a doctor if you feel eye pain

• changes in vision occur
• redness or irritation of the eye gets worse or lasts more than 72 hours

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

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

INDICATIONS & USAGE

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed
• children under 6 years of age; ask a doctor

STORAGE AND HANDLING

Other information

• some users may experience a brief tingling sensation
• store at 15° to 25°C (59° to 77°F)

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOUND BODY ARTIFICIAL TEARS 
polyvinyl alcohol, povidone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-565
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL	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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-565-15	1 in 1 BOX
1		15 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	02/25/2014

Labeler - United Exchange Corp. (840130579)