Otc - Active Ingredient
Menthol 5%
Aemerry Numbing Cream
FDA Label NDC 87615-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Da Capo Prima Llc for the product Aemerry Numbing Cream (NDC 87615-002). 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, dosage & administration, warnings, otc - keep out of reach of children, indications & usage, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Local Anesthetic
Dosage & Administration
Temporarily relieves local and anorectal discomfort associated with the anorectal disorder or swelling.
Warnings
For external use only
Do not use this product if
- youare allergic to lidocaine.
- in case of accidental overdose, seek immedidate medical help or contact the Poison Control Center.
- seal is broken or missing.
- donot exceed the recommended daily dosage unless directed by a doctor. Certain sensitive individualsmayhave an allergic reaction to some of the ingredients of this product.
- do not put this cream into the rectum using your fingers, applicators, or any medical devices.
When using this product
Stop use and ask a doctor if
the symptom being treated does not improve, or ifredness,irritation, swelling, pain, or other symptoms appear or worsen. Seek medical help right away.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek medical help right away.
Indications & Usage
- Children(under 12 yearsof age):consult a doctor.
- Adults: before applying this product, cleanthe affected area with mild soap andwarm water and rinsethoroughly.Pat drythe area with a soft cloth or tissue.
- Apply up to 3 times a day.
Other Safety Information
- Keep away from direct sunlight or heat.
- Store at room temperature 59°-86°F (15°-30°C).
Inactive Ingredient
Aqua, Propylene Glycol, Carbomer 934, Lecithin(Soybean),Tocopheryl Acetate, Benzyl Alcohol.
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