FDA Label for Sound Body Artificial Tears

View Indications, Usage & Precautions

Sound Body Artificial Tears Product Label

The following document was submitted to the FDA by the labeler of this product United Exchange Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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




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