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| Product NDC Code | 73698-281 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sclera care topical anesthetic gel |
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| Type | Brand | ||||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 1372891 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | ScleraCare, LLC | ||||||
| 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 Ingredient: Lidocaine hydrochloride 3.00% Purpose Topical Anesthetic
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: • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. • Children under two-years of age: Consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: a-Bisabalol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Opuntia Vulgaris (Prickly Pear) Extract, Persea gratissima (Avocado) Oil, Phenoxyethanol, Polysorbate-20, Sodium Alginate, Squalane, Triethanolamine.
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.Uses: • For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.
Purpose
Information about the drug product’s indications for use.Purpose Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDE ALLANTOIN ALOE VERA LEAF WATER BUTYLENE GLYCOL CUCUMBER ETHYLHEXYLGLYCERIN AVOCADO OIL PHENOXYETHANOL POLYSORBATE 20 SODIUM ALGINATE SQUALANE TROLAMINE LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE
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.Package Labeling:5ml Label
Package Labeling:118ml Label2
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: • Store at room temperature
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 • in large quantities, particularly over raw surfaces or blistered areas
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. • Do not apply to wounds or damaged skin. • Do not bandage tightly.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Question? 337-526-6744 (M-F) (9-5pm CST)
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 symptoms persist for more than seven days.
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 • Avoid contact with eyes
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast feeding, • contact a physician prior to use.
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: • not intended for ingestion. For external use only When using this product • Avoid contact with eyes Do not use • in large quantities, particularly over raw surfaces or blistered areas Stop use and ask a doctor if symptoms persist for more than seven days. Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center right away. • Do not apply to wounds or damaged skin. • Do not bandage tightly. If pregnant or breast feeding, • contact a physician prior to use.
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