Label: BIOLLE TEARS- carboxymethylcellulose sodium, unspecified form solution/ drops

  • Category: HUMAN OTC DRUG LABEL

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 March 25, 2016

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  • 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

    image

    To open, twist and pull tab to remove.

    image

    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

    PRINCIPAL DISPLAY PANEL - 0.6 mL Vial Carton
  • INGREDIENTS AND APPEARANCE
    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)
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