Label: 085 LUBRICATING EYE DROPS- lubricating eye drops solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 14, 2024

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  • DOSAGE & ADMINISTRATION

  • WARNINGS

    Warnings for External use only. HydroPure Box

  • INACTIVE INGREDIENT

    Inactive ingredients: borate, boric acid, sodium chloride, calcium chloride, l-carnitine, sodium hyaluronate

    HydroPure box inactive ingredients

  • INDICATIONS & USAGE

    Uses

    *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 temporarily relieve dryness of the eye HydroPure Box Uses section

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children * If swallowed, get medical help or contact a Poison Control Center right away

    HydroPure box Keep out of reach section

  • PURPOSE

    I am not sure what is meant by purpose. There are the uses which is this section:

    Uses

    *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 temporarily relieve dryness of the eye

    Then in the active ingredients section it describes the purpose like this:

    Active ingredient Purpose

    Glycerin 0.25%................................... Eye Lubricant

    HydroPure box uses section

  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Glycerin 0.25%................................... Eye Lubricant

    HydroPure box active ingredient

  • PRINCIPAL DISPLAY PANEL

    HydroPure box and label Page 1.jpg

    HydroPure box and label Page 2.jpg HydroPure box HydroPure label

  • INGREDIENTS AND APPEARANCE
    085 LUBRICATING EYE DROPS 
    lubricating eye drops solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84227-851
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LEVOCARNITINE (UNII: 0G389FZZ9M)  
    BORATE ION (UNII: 44OAE30D22)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84227-851-101 in 1 CARTON05/15/2024
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01805/15/2024
    Labeler - OTE North America (963905034)
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