Label: HYDRATE LUBRICANT- polyethylene glycol 400 and propylene glycol solution/ drops

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

Drug Label Information

Updated March 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients Purposes
    Polyethylene glycol 400 0.04%Lubricant
    Propylene glycol 0.3%Lubricant
  • Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
  • Warnings

    For external use only

    Do not use

    • if this product changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product

    When using this product

    • to avoid contamination do not touch tip of container to any surface
    • replace cap after each use
    • remove contacts before using

    Stop use and ask a doctor if you experience any of the following

    • eye pain
    • changes in vision
    • continued redness or irritation of the eye
    • 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 (1-800-222-1222) right away.

  • Directions

    • shake well before using
    • Instill 1 or 2 drops in the affected eye(s) as needed
  • Other information

    store at 15°-30°C (59°-86°F)

  • Inactive Ingredients

    Aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions?

    866-778-0043 Alchemy43.com

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Sproose Products Inc.
    West Hollywood, CA

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    ALCHEMY 43

    HYDRATE

    LUBRICANT
    EYE DROPS

    STERILE 0.5 FL. OZ (15mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    HYDRATE LUBRICANT 
    polyethylene glycol 400 and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83716-6000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.004 g  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.003 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83716-6000-11 in 1 CARTON09/01/2023
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01809/01/2023
    Labeler - Sproose Products Inc. (119019937)
    Establishment
    NameAddressID/FEIBusiness Operations
    Samson Pharmaceuticals Inc.088169581MANUFACTURE(83716-6000)
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