Active Ingredient:
Lidocaine hydrochloride 3.00%
Sclera Care Topical Anesthetic Gel
FDA Label NDC 73698-281
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Scleracare, Llc for the product Sclera Care Topical Anesthetic Gel (NDC 73698-281). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient:, purpose, uses:, warnings:, when using this product, do not use, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Uses:
• For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.
Warnings:
• For external use only not intended for ingestion.
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.
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 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.
Other Information:
• Store at room temperature
Question?
337-526-6744 (M-F) (9-5pm CST)
Package Labeling:5Ml
Label (Label)
Package Labeling:118Ml
Label2 (Label2)
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