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The solution numbing - Medication Information

Product NDC Code 82617-105
Drug Name

The solution numbing

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine hydrochloride 5 g/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 1245194
Application Number M017
Labeler Name SCALP TECH INC
Packages
Package NDC Code Description
82617-105-60 60 ml in 1 bottle (82617-105-60)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENTS LIDOCAINE HYDROCHLORIDE 5%

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 ADULT CLEANSE THE AFFECTED AREA WITH: MILD SOAP AND WARM WATER AND RINSE THOROUGHLY/BY PATTING OR BLOTTING WITH AN APPROPRIATE CLEANSING PAD. GENTLY DRY BY PATTING OR BLOTTING WITH TOILET TISSUE OR A SOFT CLOTH BEFORE APPLICATION OF THIS PRODUCT CHILDREN UNDER 12 YEARS OF AGE: CONSULT A PHYSICIAN APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 6 TIMES DAILY DO NOT USE MORE OFTEN THAN DIRECTED GENTLY APPLY TO THE AFFECTED AREA BY PATTING AND THEN DISCARD (PAD)

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS WATER/AQUA, ALCOHOL DENAT, PROPANEDIOL, ETHOXYDIGLYCOL, CARBOMER, TRIETHANOLAMINE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

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.
USES FOR THE TEMPORARY RELIEF OF DISCOMFORT AND ITCHING IN THE PERIANAL AREA HEMORRHOIDS, ANORECTAL DISORDERS, INFLAMED HEMORRHOIDAL TISSUES, ANORECTAL INFLAMMATION, HEMORRHOIDAL TISSUES OR PILES PAIN SORENESS BURNING

Purpose

Information about the drug product’s indications for use.
PURPOSE LOCAL ANESTHETICS

Spl product data elements

Usually a list of ingredients in a drug product.
THE SOLUTION NUMBING LIDOCAINE HYDROCHLORIDE TROLAMINE ETHYLHEXYLGLYCERIN ALCOHOL DIETHYLENE GLYCOL MONOETHYL ETHER LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS WATER ALLANTOIN PROPANEDIOL CARBOMER 934 PHENOXYETHANOL

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.
LABEL

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, CALL A POISON CONTROL CENTRE OR GET MEDICAL HELP RIGHT AWAY.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
QUESTIONS? CALL - 1 (403) 901-8244

Storage and handling

Information about safe storage and handling of the drug product.
OTHER INFORMATION STORE AT ROOM TEMPERATURE (15° - 30°C)

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 STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS, CONSULT A PHYSICIAN; DO NOT EXCEED THE RECOMMENDED DAILY DOSAGE, UNLESS DIRECTED BY A PHYSICIAN; IN CASE OF BLEEDING, CONSULT A PHYSICIAN PROMPTLY; DO NOT PUT THIS PRODUCT INTO THE RECTUM BY USING FINGERS OR ANY MECHANICAL DEVICE OR APPLICATOR. 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 PHYSICIAN.

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