BIOLLE TEARS- carboxymethylcellulose sodium, unspecified form solution/ drops 
SAGE Ethnographic Research, dba Biollé

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.

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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

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For temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
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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

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Use before expiration date marked on container.
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Store at 59-86 F (15-30C).
-
Retain this carton for future reference.

Warnings

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For external use only.
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To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
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If solution changes color or becomes cloudy, do not use.

Directions

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To open, twist and pull tab to remove.

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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

PRINCIPAL DISPLAY PANEL - 0.6 mL Vial Carton
BIOLLE TEARS 
carboxymethylcellulose sodium, unspecified form solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69994-001
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311) (Carboxymethylcellulose - UNII:05JZI7B19X) Carboxymethylcellulose Sodium, Unspecified Form5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Calcium Chloride (UNII: M4I0D6VV5M)  
Magnesium Chloride (UNII: 02F3473H9O)  
Potassium Chloride (UNII: 660YQ98I10)  
Water (UNII: 059QF0KO0R)  
Sodium Chloride (UNII: 451W47IQ8X)  
Sodium Lactate (UNII: TU7HW0W0QT)  
Hydrochloric Acid (UNII: QTT17582CB)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69994-001-3232 in 1 CARTON
14 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:69994-001-7272 in 1 CARTON
24 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:69994-001-10102 in 1 CARTON
34 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC:69994-001-022 in 1 CARTON
44 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
5NDC:69994-001-5252 in 1 CARTON
54 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
6NDC:69994-001-044 in 1 CARTON
64 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
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: 3/2016
Document Id: 96c60497-1326-4cf4-a63f-60b28164948d
Set id: f3d6856a-d447-4745-89e7-86cac83ce579
Version: 1
Effective Time: 20160325
 
SAGE Ethnographic Research, dba Biollé