Label: OPTIMEL MANUKA FORTE EYE GEL- glycerin gel

  • NDC Code(s): 73024-429-10
  • Packager: Melcare Biomedical Pty Ltd
  • Category: HUMAN OTC DRUG LABEL

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

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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 hypersensitive to bee products or food gums.
    • if solution changes color or becomes cloudy.
    • if box seal is broken or packaging is damaged.
    • serious conditions should be managed under the supervision of a doctor.
  • When using this product

    • to avoid contamination, do not touch tip of container to any surface.
    • replace cap after using.
    • do not overtighten cap.
    • 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 changes in vision
    • continued redness or irritation of the eye.
    • condition worsens or persists for more than 72 hours.
    • you have any reaction other than transient stinging and redness.
    • 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.
    • Remove cap, do not allow nozzle to touch any surface.
    • Instill 1 drop to the inner corner of the affected OR dispense onto tip of cotton bud and gently apply along lower lid margin up to 3 times daily or as directed.
  • Other information

    • Single patient use only.
    • Discard 2 months after opening.
    • Store below 25°C (77°F).
    • Tube is oversized to allow contents to expand during sterilization.
  • Inactive ingredients

    Honey ( Leptospermum spp.), Gum Arabic, Water.

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    optimelgel

  • INGREDIENTS AND APPEARANCE
    OPTIMEL MANUKA FORTE EYE GEL 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73024-429
    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)  
    ACACIA (UNII: 5C5403N26O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73024-429-101 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!