Soundbody Advanced Relief
FDA Label NDC 65923-637

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 Advanced Relief (NDC 65923-637). 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 - when using, otc - stop use, otc - pregnancy or breast feeding, 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

→ Otc - Purpose

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Indications & Usage

→ Storage And Handling

→ Inactive Ingredient

→ Dosage & Administration

→ Package Label.principal Display Panel

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