Revitalize Energizing Eye Drops Liquid
FDA Label NDC 82864-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Revitalize Energy Inc. for the product Revitalize Energizing Eye Drops (NDC 82864-001). 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 active ingredient                                              purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                                              Purpose

Naphozoline Hydrochloride 0.03%                      Redness Reliver
Propylene Glycol      1.0%                                 Lubricant

Uses

  • Temporarily relieves burning and irritation due to dryness of the eye
  • Relieves redness of the eye due to minor eye irritations

Warnings

For external use only

For use in the eyes only, do not drink

Ask a doctor before use if you have narrow angle glaucoma

When using this product


• Do not touch tip of container to any surface to avoid contamination
• Replace each cap after each use
• Do not use if solution changes color or becomes cloudy
• Overuse may cause more eye redness
• Pupils may become enlarged temporarily
• Remove contact lenses before use


Stop Use and ask a doctor if
• You feel eye pain
• Changes in vision occur
• Redness or irritation of the eyes lasts
• Condition worsens or lasts more than 72 hours


Keep out of reach of children
• If swallowed, get medical help or contact a Poison Control center right away

Directions

Put 1 or 2 drops in the affected eye(s) up to 4 times daily
Tightly screw on cap to seal after use

Other Information

Store at 20 - 30˚C (68-86˚F)

Inactive Ingredients

Benzalkonium Chloride, Boric Acid, Borneol, Caffeine, Camphor, menthol, potassium l-aspartate, purified water, Taurine

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