Active Ingredients
LIDOCAINE 5%
Acolye Numbing Cream Anorectal(hemorrhoidal) Cream
FDA Label NDC 60771-0029
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Haishi Biological Technology Co., Ltd. for the product Acolye Numbing Cream Anorectal(hemorrhoidal) Cream (NDC 60771-0029). 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 use, do not use, when using, 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
For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders
Uses
Directions
Adults: 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.Children under 12 years of age: Consult a doctor.
Apply externally to the affected area up to 6 times daily.
Warnings
For external use only
Stop Use
Stop using and ask a doctor if:
Condition worsens or does not improve within 7 days.
An allergic reaction occurs to ingredients in this product.
The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
Symptoms clear up and return within a few days.
Keep out of reach of children.
If swallowed, get medical help.
If pregnant or breastfeeding, ask a health professional before use.
Do Not Use
on damaged or broken skin.
When Using
When using this product:
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.
Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Inactive Ingredients
Water: 82%
Arnica: 2%
Emu oil: 2%
Lecithin (Soybean): 2%
Propylene Glycol: 2%
Tocopheryl Acetate: 2%
Carbomer 934: 2%
Benzyl Alcohol: 1%
Dosage & Administration
Adults and children 12 years and older: Apply externally to the affected area. APPLY UP TO 6 TIMES DAILY.
Children under 12 years of age: Consult a doctor.
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