BIOLLE TEARS- carboxymethylcellulose sodium, unspecified form solution/ drops

Biolle Tears by

Drug Labeling and Warnings

Biolle Tears by is a Otc medication manufactured, distributed, or labeled by SAGE Ethnographic Research, dba Biollé. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

WARNINGS

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

- 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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BIOLLE TEARS 
carboxymethylcellulose sodium, unspecified form solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69994-001
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311) (Carboxymethylcellulose - UNII:05JZI7B19X)	Carboxymethylcellulose Sodium, Unspecified Form	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69994-001-32	32 in 1 CARTON
1		4 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 69994-001-72	72 in 1 CARTON
2		4 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 69994-001-10	102 in 1 CARTON
3		4 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4	NDC: 69994-001-02	2 in 1 CARTON
4		4 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
5	NDC: 69994-001-52	52 in 1 CARTON
5		4 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
6	NDC: 69994-001-04	4 in 1 CARTON
6		4 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	06/01/2015

Labeler - SAGE Ethnographic Research, dba Biollé (079824445)