Active Ingredients
LIDOCAINE HYDROCHLORIDE 5%
The Solution Numbing Gel
FDA Label NDC 82617-105
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Scalp Tech Inc for the product The Solution Numbing (NDC 82617-105). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
LOCAL ANESTHETICS
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
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.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, CALL A POISON CONTROL CENTRE OR GET MEDICAL HELP RIGHT AWAY.
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)
Other Information
STORE AT ROOM TEMPERATURE (15° - 30°C)
Inactive Ingredients
WATER/AQUA, ALCOHOL DENAT, PROPANEDIOL, ETHOXYDIGLYCOL, CARBOMER, TRIETHANOLAMINE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN
Questions?
CALL - 1 (403) 901-8244
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