Soundbody Long Lasting Lubricant
FDA Label NDC 65923-644

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Soundbody Long Lasting Lubricant (NDC 65923-644). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients                                         Purpose

Polyethylene glycol 400 0.4%....................... Lubricant

Propylene glycol 0.3%................................. Lubricant

Otc - Purpose

Uses

For the temporary relief of burning and irritation due to eye dryness

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

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

Otc - When Using

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use

Otc - Stop Use

Stop use and ask a doctor if

  • you experience eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

If swallwed, get medical help or contact a Posion Control Center immediately

Indications & Usage

Directions

  • Put 1 or 2 drops in the affected eye(s) as needed

Storage And Handling

Other information

  • Store at 15° to 30°C (59° to 86°F)

Inactive Ingredient

Inactive ingredients

boric acid, calcium chloride, chlorhexidine gluconate, hydrochloric acid, hypromellose 2910, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide, zinc chloride

Dosage & Administration

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLY VIEW AVE.

CERRITOS, CA 90703 USA

Package Label.Principal Display Panel

Image Description (Soundbody Long Lasting Lubricant Eye Drops)

Image Description (Soundbody Long Lasting Lubricant Eye Drops)

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