Label: REGENER-EYES PRO- regener-eyes solution/ drops

  • NDC Code(s): 82305-003-01, 82305-003-02
  • Packager: Regenerative Processing Plant, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • Active Ingredient

    Glycerin, 0.5%

  • Purpose

    Eye Lubricant

  • Uses

    • For the temporary relief of burning and irritation due to dryness of the eye.
    • For use as a lubricant to prevent further irritation or to relieve dryness of the eye
    • For use as a protectant against further irritation or to relieve dryness of the eye.
  • Warnings

    External Use Only

    • To avoid contamination, do not touch tip of the bottle closure to any surface(s) including the eye or the skin.
    • Do not use if solution changes color or becomes cloudy.

    Stop use and ask a doctor If

    • You experience eye pain, changes in vision, continued redness, or irritation of the eye.
    • Condition worsens or persists for more than 72 hours.
  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center immediately.

  • Directions

    Instill 1 or 2 drops in the affected eye(s) as needed.

  • Inactive Ingredients

    Sterile Water, Tonicity Solution Sodium Chloride

  • Other information

    • Store at refrigerated conditions once the bottle closure is activated to the open position.
  • Questions?

    Questions? (800) 781-0818

  • Artwork

    82305-006-01 Box Artwork82305.003-02 BoxRegener-Eyes Ophthalmic Solution PRO

  • INGREDIENTS AND APPEARANCE
    REGENER-EYES  PRO
    regener-eyes solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82305-003
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN15 mg  in 3 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R) 15 mg  in 3 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82305-003-013 in 1 BOX08/24/2022
    13 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:82305-003-021 in 1 BOX08/24/2022
    23 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 DrugM01808/24/2022
    Labeler - Regenerative Processing Plant, LLC (079446889)
    Establishment
    NameAddressID/FEIBusiness Operations
    Regenerative Processing Plant079446889manufacture(82305-003) , label(82305-003) , pack(82305-003) , analysis(82305-003)
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