SOUNDBODY EYE LUBRICANT- polyethylene gloycol, propylene glycol liquid 
Kareway Product, Inc.

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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Soundbody Lubricant Eye Drops Ultra

Active ingredients

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Purpose

Lubricant

Lubricant

Uses

Warnings

For external use only.

Do not use

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

When using this product

  • 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(s) gets worse, persists or lasts more than 72 hours

Keep out of reach of children.

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

Directions

Other information

Store at room temperature.

Inactive ingredients

benzalkonium chloride, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, purified water, sodium chloride, sodium hydroxide

Soundbody Lubricant Eye Drops Ultra

carton

SOUNDBODY EYE LUBRICANT 
polyethylene gloycol, propylene glycol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0649
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4004 mg  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0649-51 in 1 BOX05/30/2018
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34905/30/2018
Labeler - Kareway Product, Inc. (121840057)

Revised: 7/2022
Document Id: e3574bbc-ffcf-6d48-e053-2995a90a7c86
Set id: 6d880dd9-d58b-ddf4-e053-2991aa0a1b5d
Version: 3
Effective Time: 20220708
 
Kareway Product, Inc.