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Biolle Tears

Dosage form: solution/ drops
Ingredients: Carboxymethylcellulose Sodium, Unspecified Form 5mg in 1mL
Labeler: SAGE Ethnographic Research, dba Biollé
NDC Code: 69994-001

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Biollé Tears®

Drug Facts

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.

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.

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
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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

To open, twist and pull tab to remove.

Drop 1 to 2 drops in the affected eye as needed and discard the container.

Distributed by:
Biollé a Division of SAGE
Ethnographic Research.
PO Box 1386
New York, NY 10185

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

BIOLLE TEARS 
carboxymethylcellulose sodium, unspecified form solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69994-001
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carboxymethylcellulose Sodium, Unspecified Form (Carboxymethylcellulose) Carboxymethylcellulose Sodium, Unspecified Form5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Calcium Chloride 
Magnesium Chloride 
Potassium Chloride 
Water 
Sodium Chloride 
Sodium Lactate 
Hydrochloric Acid 
Sodium Hydroxide 
Packaging
#Item CodePackage Description
1NDC:69994-001-3232 VIAL, SINGLE-USE in 1 CARTON
14 mL in 1 VIAL, SINGLE-USE
2NDC:69994-001-7272 VIAL, SINGLE-USE in 1 CARTON
24 mL in 1 VIAL, SINGLE-USE
3NDC:69994-001-10102 VIAL, SINGLE-USE in 1 CARTON
34 mL in 1 VIAL, SINGLE-USE
4NDC:69994-001-022 VIAL, SINGLE-USE in 1 CARTON
44 mL in 1 VIAL, SINGLE-USE
5NDC:69994-001-5252 VIAL, SINGLE-USE in 1 CARTON
54 mL in 1 VIAL, SINGLE-USE
6NDC:69994-001-044 VIAL, SINGLE-USE in 1 CARTON
64 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34906/01/2015
Labeler - SAGE Ethnographic Research, dba Biollé (079824445)

Revised: 03/2016
 
SAGE Ethnographic Research, dba Biollé

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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