Otc - Active Ingredient
Benzocaine 18% (w/w), Tetracaine 2% (w/w), Inactive Ingredients;
water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer,
Sodium Hyaluronate, castor oil,Innovatech Inc, Net Wt. 15g
Cutiecaine
FDA Label NDC 50876-182
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Innovatech Inc for the product Cutiecaine (NDC 50876-182). 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, otc - keep out of reach of children, adverse reactions, warnings, otc - purpose, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 not 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.
Otc - Keep Out Of Reach Of Children
Keep both used and unused medicine out of the reach of children or pets
Adverse Reactions
Stop 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.
Warnings
Do not use in or near the eyes• Do not 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.
Otc - Purpose
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
Inactive Ingredient
Inactive Ingredients;
water, Isoprpopyl Alcohol, glycerin, Ethyl alcohol, Staeric Acid, Carbomer,
Sodium Hyaluronate, castor oil, sodium lauryl sulfate,
Indications & Usage
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
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