FDA.reportPublic FDA data

THE SOLUTION

Manufacturer
SCALP TECH INC
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:53:21

Label at a glance#

ProductTHE SOLUTION
Active ingredientLIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

FOR THE TEMPORARY RELIEF OF LOCAL AND ANORECTAL ITCHING, DISCOMFORT, AND PAIN ASSOCIATED WITH ANORECTAL DISORDERS OR ANORECTAL INFLAMMATION.

Dosage and administration

CLEAN THE AFFECTED AREA. SENSITIVITY AND POSSIBLE ALLERGY TESTS ADVISED PRIOR TO USE. SPRAY SPARINGLY TO AFFECTED AREA AFTER THOROUGHLY CLEANSING. WAIT UNTIL ANESTHETIC EFFECT OCCURS. YOU MAY REAPPLY TO CONTINUE NUMBING AFFECT. APPLY TO THE AFFECTED AREA UP TO 4 TIMES DAILY. CHILDREN UNDER 12 YEARS OF AGE, CONSULT A DOCTOR.

Storage and handling

STORE IN COOL DARK PLACE OR REFRIGERATE. KEEP AWAY FROM DIRECT SUNLIGHT OR HEAT. DISCARD AFTER EXPIRATION DATE.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

LIDOCAINE HCL 5%

EPINEPHRINE HCL .01%

PURPOSE

OTC - PURPOSE SECTION

LOCAL ANESTHETICS

VASOCONSTRICTOR

USES

INDICATIONS & USAGE SECTION

FOR THE TEMPORARY RELIEF OF LOCAL AND ANORECTAL ITCHING, DISCOMFORT, AND PAIN ASSOCIATED WITH ANORECTAL DISORDERS OR ANORECTAL INFLAMMATION.

WARNINGS

WARNINGS SECTION

  • FOR EXTERNAL USE ONLY.
  • AVOID CONTACT WITH THE EYES.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

DO NOT USE THIS PRODUCT IF:

OTC - DO NOT USE SECTION

  • PREGNANT OR BREASTFEEDING, ASK A HEALTH PROFESSIONAL BEFOR EUSE.
  • TAMPER EVIDENT "DO NOT USE THIS PRODUCT" IF SAFETY SEAL IS BROKEN OR MISSING.
  • YOU HAVE A HEART CONDITION, HIGH BLOOD PRESSURE, THYROID DISEASE, DIABETES, OR DIFFICULTY IN URINATION DUE TO ENLARGEMENT OF PROSTATE GLAND UNLESS DIRECTED BY A DOCTOR.

WHEN USING THIS PRODUCT:

OTC - WHEN USING SECTION

  • DO NOT EXCEED THE RECOMMENDED DAILY USAGE.
  • CERTAIN PERSONS CAN DEVELOP ALLERGIC REACTIONS TO INGREDIENTS IN THIS PRODUCT.
  • DO NOT PUT THIS PRODUCT INTO THE RECTUM BY USING FINGERS OR ANY MEDICAL DEVICE OR APPLICATOR.
  • IF SWALLOWED, CALL YOUR POISON CONTROL CENTER AT 1(800)222-1222.
  • IF CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS, CONSULT A DOCTOR.

STOP USE AND ASK A DOCTOR IF:

OTC - STOP USE SECTION

  • THE SYMPTOM BEING TREATED DOES NOT SUBSIDE, OR REDNESS, IRRITATION, SWELLING, PAIN, OR OTHER SYMPTOMS DEVELOP OR INCREASE.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • CLEAN THE AFFECTED AREA.
  • SENSITIVITY AND POSSIBLE ALLERGY TESTS ADVISED PRIOR TO USE. SPRAY SPARINGLY TO AFFECTED AREA AFTER THOROUGHLY CLEANSING. WAIT UNTIL ANESTHETIC EFFECT OCCURS. YOU MAY REAPPLY TO CONTINUE NUMBING AFFECT.
  • APPLY TO THE AFFECTED AREA UP TO 4 TIMES DAILY.
  • CHILDREN UNDER 12 YEARS OF AGE, CONSULT A DOCTOR.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • STORE IN COOL DARK PLACE OR REFRIGERATE.
  • KEEP AWAY FROM DIRECT SUNLIGHT OR HEAT.
  • DISCARD AFTER EXPIRATION DATE.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ALLANTOIN, CAPRYLHYDOXAMIC ACID, ETHOXYDIGLYCOL, 1,2-HEXANEDIOL, PROPANEDIOL, WATER

QUESTIONS?

OTC - QUESTIONS SECTION

CALL - 1 (403) 901-8244

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_The Solution Art Work_4oz01b LBL_The Solution Art Work_4oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2601579EPINEPHrine HCl 0.01 % / lidocaine HCl 5 % Rectal SprayPSN4
2601579epinephrine hydrochloride 0.1 MG/ML / lidocaine hydrochloride 50 MG/ML Rectal SpraySCD4
2601579epinephrine hydrochloride 0.01 % / lidocaine hydrochloride 5 % Rectal SpraySY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82617-101-14THE SOLUTION118 mL in 1 BOTTLE, SPRAYSPRAY1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82617-101THE SOLUTION (LIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDE) SPRAY [SCALP TECH INC]4Current NDC, Legacy NDC, 1 package rows20250122_df51623c-e0b6-8e86-e053-2995a90a59b2.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
82617-10182617-101-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
WATER059QF0KO0RIACT
ALLANTOIN344S277G0ZIACT
PROPANEDIOL5965N8W85TIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
EPINEPHRINE HYDROCHLORIDEWBB047OO38ACTIB

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 SOLUTIONLIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDESCALP TECH INCdf51623c-e0b6-8e86-e053-2995a90a59b22025-01-08WarningsExact identifier
ndc (package): 82617-101-14
ndc (product): 82617-101
ndc11 (package): 82617010114
spl id: 2b369998-00c4-fcb6-e063-6294a90af2eb
spl set id: df51623c-e0b6-8e86-e053-2995a90a59b2

Reported adverse events (FAERS/openFDA)#

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