Label: OPTIMEL MANUKA DRY EYE DROPS- glycerin solution/ drops

  • NDC Code(s): 73024-399-10
  • Packager: Melcare Biomedical Pty Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 April 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Glycerin 0.2%

  • Purpose

    Lubricant

  • Uses

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

    For external use only

  • Do not use

    • if you have a history of hypersensitivity or sensitive to honey or benzoate preservatives without seeking medical advice.
    • if solution changes color or becomes cloudy.
    • if packaging is damaged.
    • serious conditions should be managed under the supervision of a doctor.
  • When using this product

    • Before first use: check tamper ring is attached to cap base – remove cap and discard ring.
    • to avoid contamination, do not touch tip of container to any surface.
    • replace cap after using.
    • remove contact lenses before using.
    • wait at least 10 minutes before contact lens insertion.
    • Initial stinging and redness on drop application is to be expected.
  • Stop use and ask a doctor if

    • You experience eye pain change in vision, continued redness or irritation of the eye.
    • Condition worsens
  • Keep out of reach of children.

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

  • Directions

    • Wash hands.
    • Instill 1 drop to the inner corner of the affected of the affected eye up to 3 times daily.
    • Children under 16 years of age ask a doctor.
  • Other information

    • Single patient use only.
    • Discard 2 months after opening.
    • Store below 25°C (77°F).
  • Inactive ingredients

    Honey ( Leptospermum spp.), Sodium benzoate, Sodium chloride, Water.

  • Questions?

    Web: www.melcare.com
    Email: info@melcare.com
    Phone: 8557082611

  • PRINCIPAL DISPLAY PANEL

    optimeldrops

  • INGREDIENTS AND APPEARANCE
    OPTIMEL MANUKA DRY EYE DROPS 
    glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73024-399
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HONEY (UNII: Y9H1V576FH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73024-399-101 in 1 CARTON07/19/2019
    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 finalpart34907/19/2019
    Labeler - Melcare Biomedical Pty Ltd (743166886)
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