Active Ingredients
Lidocaine 5%
Adellina Lidocaine Numbing Cream Topical Anorectal Cream
FDA Label NDC 83566-612
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 Adellina Lidocaine Numbing Cream Topical Anorectal Cream (NDC 83566-612). 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 and ask a doctor if, do not use this product if, when using this product, 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.
For the temporary reliefof pain.
Uses
Adults: Clean the affected area with mild soap and warm water and rinse thoroughly.
Gently dry by patting with toilet tissue or a soft cloth before application of this product.
Children under 12 years of age: consult a doctor.
Warnings
For external use only.
Stop Use And Ask A Doctor If
discomfort persists for 7 days.
Certain persons can develop allergic reactions to ingredients in thisproduct. If redness, irritation, swelling, pain, or other symptoms occuror worsen, discontinue use and consult a doctor.
Do Not Use This Product If
Pregnant or breastfeeding, ask a 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.
When Using This Product
do not exceed the recommended daily dosage unless directed by a doctor.
Some individuals may experience allergic reactionsto the ingredients contained in this product.
Do not put this product into the rectum by using fingers or any mechanical device or applicator. If condition worsens or does not improve within 7 days, consult a doctor. In case of bleeding, consult adoctor promptly.
Keep Out Of Reach Of Children
In case of accidental ingestion, seek medical help immediately.
Dosage & Administration
Apply externally to the affected area up to 6 times daily.
Inactive Ingredients
WATER,PROPYLENE GLYCOL,CARBOMER HOMOPOLYMER,GLYCERIN,EDETATE DISODIUM,HYDROXYACETOPHENONE1,2-HEXANEDIOL,CHRYSANTHELLUM INDICUM TOP,PURSLANE,POLYOXYL PEG-40 HYDROGENATED CASTOR OIL
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