The following Structured Product Label (SPL) was submitted to the FDA by Innovatech Inc for the product Cutiecaine (NDC 50876-111). 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 otc - active ingredient, dosage & administration, otc - do not use, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Cutiecaine, Topical Lidocaine Cream (4% w/w),Active Ingredient; Lidocaine Hydrochloride 4% (w/w), Inactive Ingredients;
water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer,
Sodium Hyaluronate, castor oil,Innovatech Inc, Net Wt. 15g
Dosage & Administration
Use for reducing pain or discomfort from minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy, hemorrhoids pain and Itching. Use small amount (1 to 2 gm) of this medication, apply on the skin with gentle massage to numb the skin or relieve pain (do not occlude). Children under 2 years of age, consult your doctor
Otc - Do Not Use
• Do not use in or near the eyes• Do use in large amount particularly over the raw surfaces or blistersStop use and Ask Doctors if• Allergic reactions occurs• Condition worsen and does not improve• Symptoms clean up and returns within few day• itching, redness, burning , swelling or other symptoms occurs• Keep both used and unused medicine out of the reach of children or pets• If swallowed get medical attention right away Call your doctor immediately.
Package Label.Principal Display Panel
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