Label: BIOLLE GEL TEARS- carboxymethylcellulose sodium, unspecified form solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 69994-002-02, 69994-002-04, 69994-002-10, 69994-002-32, view more69994-002-52, 69994-002-72 - Packager: SAGE Ethnographic Research, dba Biollé
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 13, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Inactive Ingredients
- Uses
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Other Information
- Warnings
- Directions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 32 Vial Carton
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INGREDIENTS AND APPEARANCE
BIOLLE GEL TEARS
carboxymethylcellulose sodium, unspecified form solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69994-002 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 10 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:69994-002-32 32 in 1 CARTON 06/01/2015 1 0.6 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:69994-002-72 72 in 1 CARTON 06/01/2015 2 0.6 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 3 NDC:69994-002-10 102 in 1 CARTON 06/01/2015 3 0.6 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 4 NDC:69994-002-02 2 in 1 CARTON 06/01/2015 4 0.6 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 5 NDC:69994-002-52 52 in 1 CARTON 06/01/2015 5 0.6 mL in 1 VIAL, SINGLE-USE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 6 NDC:69994-002-04 4 in 1 CARTON 06/01/2015 6 0.6 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) Registrant - Biollé (000000000)
