Label: LUBRICANT EYE DROPS- sodium hyaluronate solution/ drops

  • NDC Code(s): 82357-1101-1, 82357-1101-2
  • Packager: MFB Global LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 7, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Sodium Hyaluronate 1%

  • PURPOSE

    Lubricant

  • DOSAGE & ADMINISTRATION

    For the temporary relief of burning and irritation due to dryness of the eye.

    For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.

    For use as a protectant against further irritation or to relieve dryness of the eye.

    For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

    Relieves redness of the eye due to minor eye irritations.

  • WARNINGS

    For external use only

  • DO NOT USE

    if solution changes color or becomes cloudy.

  • USER SAFETY WARNINGS

    if you have narrow angle glaucoma.

  • WHEN USING

    To avoid contamination, do not touch tip of container to any surface. ■ Replace cap after using. ■ Overuse of this product may produce increased redness of the eye. ■ Pupils may become enlarged temporarily.

  • ASK DOCTOR

    if ■ you experience eye pain, changes in vision, continued redness or irritation of the eye. ■ the symptom worsens or persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help of contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Instill 1 or 2 drops in the affected eye(s) as needed up to four times daily.

  • OTHER SAFETY INFORMATION

    Keep refrigerated. Store at 4-10℃(39-50℉). ■ Tamper Evident. Do not use if ring around the bottom of bottle cap is broken or missingminor eye irritations.

  • INACTIVE INGREDIENT

    Polyquaternium 1

    Purified Water.

  • 88436-1 - Section Title Not Found In Database

    1-646-339-5789

  • SPL UNCLASSIFIED SECTION

    Manufacturer: DrSignal BioTechnology Co., Ltd. (No. 2-1, Ln. 181, Sec. 2, Jiuzong Rd., Neihu Dist., Taipei City 114, Taiwan)
    Distributor: MFB Global LLC
    (136-17 39th Ave Suite 301, Flushing, NY 11354, USA) Tel: 1-646-339-5789


    Made in Taiwan

  • DESCRIPTION

    product information

  • PRINCIPAL DISPLAY PANEL

    refer to following image

  • INGREDIENTS AND APPEARANCE
    LUBRICANT EYE DROPS 
    sodium hyaluronate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82357-1101
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM3 g  in 100 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82357-1101-21 in 1 BOX11/05/2021
    1NDC:82357-1101-13 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/05/2021
    Labeler - MFB Global LLC (118369923)
    Registrant - DrSignal BioTechnology Co., Ltd. (656113584)
    Establishment
    NameAddressID/FEIBusiness Operations
    DrSignal BioTechnology Co., Ltd.656113584manufacture(82357-1101)