FDA Label for Soundbody Advanced Relief

View Indications, Usage & Precautions

Soundbody Advanced Relief 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

Dextran 70 0.1%.............................................. Lubricant

Polyethylene glycol 400 1%................................ Lubricant

Povidone 1%.................................................... Lubricant

Tetrahydrozoline HCI 0.05%............................... Redness reliever


Otc - Purpose



Uses

  • for the relief of redness of the eyes due to minor eye irritations
  • for protection against further irritation

Warnings



Ask a doctor before use if you have narrow angle glaucoma


Otc - When Using



When using this product

  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • 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 feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens 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 reach of children. If swallowed, get medical help or contact a Poision Control Center right away


Indications & Usage



Directions

  • to open bottle, push cap down and twist counterclockwise. To close bottle, twist clockwise until it stops turning.
  • put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • 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°-25°C (59°-77°F)

Inactive Ingredient



Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride


Dosage & Administration



DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

Made in Korea


Package Label.Principal Display Panel




* Please review the disclaimer below.