FDA.reportPublic FDA data

THE SOLUTION 2.0

Manufacturer
SCALP TECH INC
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:32:17

Label at a glance#

ProductTHE SOLUTION 2.0
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

TEMPORARILY RELIEVES SYMPTOMS DUE TO HEMORRHOIDS, HEMORRHOIDAL TISSUES OR PILES: ITCHING PAIN SORENESS BURNING

Dosage and administration

ADULTS AND CHILDREN 12 YEARS AND OVER CLEANSE THE AFFECTED AREA WITH MILD SOAP AND WARM WATER RINSE WELL OR PAT WITH AN APPROPRIATE CLEANSING PAD GENTLY DRY BY PATTING OR BLOTTING WITH TOILET TISSUE OR A SOFT CLOTH BEFORE APPLYING THIS PRODUCT USE SPRAY PUMP TO APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 4 TIMES DAILY DO NOT USE MORE OFTEN THAN DIRECTED

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

LIDOCAINE HCL 5%

PURPOSE

OTC - PURPOSE SECTION

LOCAL ANESTHETIC

USES

INDICATIONS & USAGE SECTION

TEMPORARILY RELIEVES SYMPTOMS DUE TO HEMORRHOIDS, HEMORRHOIDAL TISSUES OR PILES:

  • ITCHING
  • PAIN
  • SORENESS
  • BURNING

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU HAVE

  • HEART DISEASE
  • HIGH BLOOD PLESSURE
  • THYROID DISEASE
  • DIABETES
  • DIFFICULTY IN URINATION
  • TAKE MEDICINE FOR
  • HIGH BLOOD PRESSURE
  • DEPRESSION

WHEN USING THIS PRODUCT DO NOT PUT INTO THE RECTUM BY USING FINGERS OR ANY MECHANICAL DEVICE OR APPLICATOR.

STOP USE AND ASK A DOCTOR IF

  • BLEEDING OCCURS
  • CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS
  • REDNESS, IRRITATION, SWELLING, PAIN OR OTHER SYMPTOMS OCCUR
  • YOU EXPERIENCE
  • WEAKNESS
  • CONFUSION
  • HEADACHE
  • DIFFICULTY BREATHING
  • PALE, GREY OR BLUE COLOURED SKIN.

tHESE MIGHT BE SIGNS OF METHEMOGLOBINEMIA, A RARE DISORDER, WHICH MAY APPEAR UP TO 2 HOURS AFTER USE.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

ADULTS AND CHILDREN 12 YEARS AND OVER

  • CLEANSE THE AFFECTED AREA WITH MILD SOAP AND WARM WATER
  • RINSE WELL OR PAT WITH AN APPROPRIATE CLEANSING PAD
  • GENTLY DRY BY PATTING OR BLOTTING WITH TOILET TISSUE OR A SOFT CLOTH BEFORE APPLYING THIS PRODUCT
  • USE SPRAY PUMP TO APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 4 TIMES DAILY
  • DO NOT USE MORE OFTEN THAN DIRECTED

OTHER INFORMATION

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

AQUA, ETHOXYDIGLYCOL, PHENOXYETHANOL, ALLANTOIN, ETHYLHEXYLGLYCERIN

QUESTIONS?

OTC - QUESTIONS SECTION

+1 (403) 901 8244

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

lbllbl

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1545290lidocaine HCl 5 % Topical SprayPSN2
1545290lidocaine hydrochloride 50 MG/ML Topical SpraySCD2
1545290lidocaine hydrochloride 5 % Topical SpraySY2

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
82617-102-12THE SOLUTION 2.060 mL in 1 BOTTLE, SPRAYSPRAY602

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82617-10282617-102-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALLANTOIN344S277G0ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
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 2.0LIDOCAINESCALP TECH INC0fa423b6-cc0f-b569-e063-6294a90a239e2026-01-09WarningsExact identifier
ndc (package): 82617-102-12
ndc (product): 82617-102
ndc11 (package): 82617010212
spl id: 47f815d3-508f-241d-e063-6294a90a802a
spl set id: 0fa423b6-cc0f-b569-e063-6294a90a239e

Reported adverse events (FAERS/openFDA)#

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