FDA.reportPublic FDA data

THE SOLUTION NUMBING

Manufacturer
SCALP TECH INC
Effective date
2024-05-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:53:17

Label at a glance#

ProductTHE SOLUTION NUMBING
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and 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

Dosage and administration

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 AFFEC...

Storage and handling

STORE AT ROOM TEMPERATURE (15° - 30°C)

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

LIDOCAINE HYDROCHLORIDE 5%

PURPOSE

OTC - PURPOSE SECTION

LOCAL ANESTHETICS

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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 SECTION

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, CALL A POISON CONTROL CENTRE OR GET MEDICAL HELP RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

STORE AT ROOM TEMPERATURE (15° - 30°C)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER/AQUA, ALCOHOL DENAT, PROPANEDIOL, ETHOXYDIGLYCOL, CARBOMER, TRIETHANOLAMINE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

QUESTIONS?

OTC - QUESTIONS SECTION

CALL - 1 (403) 901-8244

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1245194lidocaine HCl 5 % Rectal GelPSN2
1245194lidocaine hydrochloride 0.05 MG/MG Rectal GelSCD2
1245194lidocaine hydrochloride 5 % Rectal GelSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82617-105-60THE SOLUTION NUMBING60 mL in 1 BOTTLEGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82617-105THE SOLUTION NUMBING (LIDOCAINE HYDROCHLORIDE) GEL [SCALP TECH INC]2Current NDC, 1 package rows20250122_184be4cc-b0b9-7882-e063-6394a90a8e7e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82617-10582617-105-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALCOHOL3K9958V90MIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
WATER059QF0KO0RIACT
ALLANTOIN344S277G0ZIACT
PROPANEDIOL5965N8W85TIACT
CARBOMER 934Z135WT9208IACT
PHENOXYETHANOLHIE492ZZ3TIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THE SOLUTION NUMBINGLIDOCAINE HYDROCHLORIDESCALP TECH INC184be4cc-b0b9-7882-e063-6394a90a8e7e2024-05-25WarningsExact identifier
ndc (package): 82617-105-60
ndc (product): 82617-105
ndc11 (package): 82617010560
spl id: 194c5386-5487-abf1-e063-6394a90a574d
spl set id: 184be4cc-b0b9-7882-e063-6394a90a8e7e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.