SOUNDBODY ARTIFICIAL TEARS- glycerin, hypromelloses, polyethylene glycol 400 liquid

Soundbody Artificial Tears by

Drug Labeling and Warnings

Soundbody Artificial Tears by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene Glycol 400 1%

Purpose

Lubricant

Lubricant

Lubricant

Use

• for the temporary relief of burning and irritation due to dryness of the eye
• for protection against further irritation

Warnings

When using this product

• remove contact lenses before using
• do not use if this solution changes color or become cloudy
• do not touch tip of container to any surface to avoid contamination
• replace cap after each use
  

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye lasts
• condition worsens or lasts more than 72 hours
  

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• Put 1 to 2 drops in the affected eye(s) up to 4 times daily
• children under 6 years of age: ask a doctor
  

Other information

• store between 15° to 25°C (59°F to 77°F)

  
  

Inactive ingredients

Ascorbic acid, benzalkonium chloride, boric acid, dextrose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate

Package principal display panel

Soundbody Artificial Tears

INGREDIENTS AND APPEARANCE

SOUNDBODY ARTIFICIAL TEARS 
glycerin, hypromelloses, polyethylene glycol 400 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0650
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 mg  in 1 mL
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO)	HYPROMELLOSES	2 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LACTATE (UNII: TU7HW0W0QT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0650-5	1 in 1 BOX	05/30/2018
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	05/30/2018

Labeler - Kareway Product, Inc. (121840057)