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Drug Facts
Distributed by:
Biollé a Division of SAGE
Ethnographic Research.
PO Box 1386
New York, NY 10185
Biolle Tears
FDA Label NDC 69994-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sage Ethnographic Research, Dba Bioll� for the product Biolle Tears (NDC 69994-001). 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 other, active ingredient, purpose, inactive ingredients, uses, otc - stop use, otc - keep out of reach of children, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Carboxymethylcellulose sodium 0.5%
Purpose
Eye lubricant
Inactive Ingredients
Boric Acid, calcium chloride; magnesium chloride, potassium chloride; purified water, sodium borate; and sodium chloride. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.
Uses
- For temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.- May be used as a protectant against further irritation.
Otc - Stop Use
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 - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other Information
- Use before expiration date marked on container.- Store at 59-86 F (15-30C).- Retain this carton for future reference.
Warnings
- For external use only.- 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.
Directions
Image (Biolle 01)
To open, twist and pull tab to remove.
Image (Biolle 02)
Drop 1 to 2 drops in the affected eye as needed and discard the container.
Principal Display Panel - 0.6 Ml Vial Carton
Preservative-Free
Biollé
Tears®
Rejuvenation in every drop
Moderate dry eye relief
32 Single-use containers
0.02 fl oz (0.6mL) each sterile
Principal Display Panel (0.6 mL Vial Carton)
* Please review the disclaimer below.
