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Local anesthetic anorectal cream - Medication Information

Product NDC Code 84767-001
Drug Name

Local anesthetic anorectal cream

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine 5 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1366789
Application Number M015
Labeler Name Make Labs LLC
Packages
Package NDC Code Description
84767-001-01 170 g in 1 tube (84767-001-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients purpose Lidocaine 5%........Local Anesthetic

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Adults: When practical, clean affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Apply externally to the affected area up to 6 times a day. Children 12 and under, consult a physician prior to use.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butyrospermum Parkii (Shea) Butter, Benzyl Alcohol, Cetearyl Alcohol, Ceteth-20, Carbomer, Cholesterol, Ethoxydiglycol, Lecithin, PPG-12/SMDI Copolymer, Propanediol, Polysorbate 60, Simmondsia Chinensis (Jojoba) Seed Oil, Water.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Stop use and ask a doctor if rectal bleeding occurs 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.

Purpose

Information about the drug product’s indications for use.
Uses Temporary relief of pain, itching, and discomfort associated with hemorrhoids

Spl product data elements

Usually a list of ingredients in a drug product.
Local Anesthetic Anorectal Cream Lidocaine ALOE VERA LEAF SHEA BUTTER CHOLESTEROL LECITHIN, SUNFLOWER AMINOMETHYLPROPANOL BENZYL ALCOHOL CETOSTEARYL ALCOHOL CETETH-20 CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE DIETHYLENE GLYCOL MONOETHYL ETHER PPG-12/SMDI COPOLYMER PROPANEDIOL POLYSORBATE 60 JOJOBA OIL WATER LIDOCAINE LIDOCAINE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
numbing.com Local Anesthetic Anorectal Cream Net Wt. 6 OZ / 170g Tube numbing cream

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only If pregnant or breast-feeding , ask a health professional before use.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API