Sound Body Artificial Tears
FDA Label NDC 65923-565

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 Sound Body Artificial Tears (NDC 65923-565). 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 - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, 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

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

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

Otc - 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

Otc - 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

Otc - 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

Otc - 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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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

Package Label.Principal Display Panel

Image Description (Pl Soundbody Artificial Tears)

Image Description (Pl Soundbody Artificial Tears)

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