OPTIMEL MANUKA DRY EYE DROPS- glycerin solution/ drops

Optimel Manuka Dry Eye Drops by

Drug Labeling and Warnings

Optimel Manuka Dry Eye Drops by is a Otc medication manufactured, distributed, or labeled by Melcare Biomedical Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

OPTIMEL MANUKA DRY EYE DROPS 
glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73024-399
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HONEY (UNII: Y9H1V576FH)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73024-399-10	1 in 1 CARTON	07/19/2019
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	07/19/2019

Labeler - Melcare Biomedical Pty Ltd (743166886)