Signature Care Eye Drops Advanced Relief Solution/ Drops
FDA Label NDC 21130-704

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands Llc for the product Signature Care Eye Drops Advanced Relief (NDC 21130-704). 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, indications & usage, warnings, otc - ask doctor, otc - when using, 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.

Otc - Active Ingredient

​Active ingredients

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

Otc - Purpose

​Purposes

Dextran 70...Lubricant

Polyethylene glycol 400...Lubricant

Povidone...Lubricant

Tetrahydrozoline HCl...Redness reliever

Indications & Usage

Uses

  • relieves redness of the eye due to minor eye irritations
  • as a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings

Warnings

For external use only

Otc - Ask Doctor

Ask a doctor before use if you have narrow angle glaucoma

Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

Otc - When Using

When using this product

  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using

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 Poison Control Center (1-800-222-1222) right away.

Dosage & Administration

Directions

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.

Other Safety Information

Other information

  • Store at 15°-30°C (59°-86°F)

Inactive Ingredient

Inactive ingredients

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

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