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| Product NDC Code | 73024-399 | ||||
|---|---|---|---|---|---|
| Drug Name | Optimel manuka dry eye drops |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| RxCUI drug identifier | 998232 | ||||
| Application Number | part349 | ||||
| Labeler Name | Melcare Biomedical Pty Ltd | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Glycerin 0.2%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Honey ( Leptospermum spp.), Sodium benzoate, Sodium chloride, Water.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use s 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.
Purpose
Information about the drug product’s indications for use.Purpose Lubricant
Spl product data elements
Usually a list of ingredients in a drug product.Optimel Manuka Dry Eye Drops Glycerin HONEY WATER SODIUM CHLORIDE SODIUM BENZOATE GLYCERIN GLYCERIN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL optimeldrops
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information Single patient use only. Discard 2 months after opening. Store below 25°C (77°F).
Questions? Web: www.melcare.com Email: [email protected] Phone: 8557082611
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if You experience eye pain change in vision, continued redness or irritation of the eye. Condition worsens
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API