Active Ingredients
LIDOCAINE 5%
Acolye Numbing Cream Anorectal(hemorrhoidal) Cream
FDA Label NDC 83566-615
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Aimu Biological Technology Co., Ltd for the product Acolye Numbing Cream Anorectal(hemorrhoidal) Cream (NDC 83566-615). 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 ingredients, purpose, uses, warnings, stop using and ask a doctor if, when using, do not use, 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
Local Anesthetic
Uses
For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders.
For the temporary relief of pain.
Warnings
For external use only
Stop Using And Ask A Doctor If
Condition worsens or does not improve within 7 days.
Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
When Using
Do not get into the eyes.
Do not exceed recommended dosage unless directed by a doctor.
Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Some individuals mayexperience allergic reactionsto the ingredients containedin this product.
In case of bleeding, consult a doctor promptly.
Do Not Use
Preganant or breastfeeding, aska health professional before use.
If there is any allergic reaction to this product.
In case of accidental overdose, get medical help, or contact the Poison Control Center immediately.
Keep Out Of Reach Of Children
If swallowed, get medical help.
Dosage & Administration
For adults and children aged 12 and older: When practical, clean the area with mild soap and warm water and rinse thoroughly.
Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.For children under 12:Consult a doctor.
Apply externally to the affected area.
Apply externally to the affected area up to 6 times daily.
Inactive Ingredients
Water,Arnica,Emu oil,Lecithin (Soybean),Propylene Glycol,Tocopheryl Acetate,Carbomer 934,Benzyl Alcohol
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