The following Structured Product Label (SPL) was submitted to the FDA by Transdermal Corp for the product Cutiecaine (NDC 51350-111). 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, otc - purpose, indications & usage, otc - keep out of reach of children, inactive ingredient, dosage & administration, warnings, 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-5%, Topical Lidocaine Cream (5% 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
Otc - Purpose
For relief of pain and discomfort from; hemorrhoids pain and Itching, Other Uses; minor cuts, bruises, sun burn, insect bites, poison ivy, etc.
Indications & Usage
Use for reducing pain or discomfort from; hemorrhoids pain and Itching. minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy, 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 - Keep Out Of Reach Of Children
Keep both used and unused medicine out of the reach of children or pets
Inactive Ingredient
Inactive Ingredients; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,SDS, 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
Warnings
• 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
Carton.jpg
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