FDA.reportPublic FDA data

ReleafPEAK HemCare

Manufacturer
Releaf Technologies LLC
Effective date
2023-11-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:59:40

Label at a glance#

ProductReleafPEAK HemCare MAXIMUM RELIEF
Active ingredientLIDOCAINE, MENTHOL
Label structure9 sections

Indications and uses

For temporary relief of pain and itching due to anorectal disorders

Dosage and administration

Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: do not use, ask a doctor.

Storage and handling

Protect product from excessive moisture - Avoid storing in direct sunlight - Store with lid tightly closed

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%
Menthol 1%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

USES

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching due to anorectal disorders

WARNING

WARNINGS SECTION

For external use only.


Do not use large quantities, particularly over raw surfaces or blistered areas.


When using this product avoid contact with the eyes.


Stop using and ask a doctor if

  • the condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • a rash or irritation develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.
Children under 12 years of age: do not use, ask a doctor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Protect product from excessive moisture - Avoid storing in direct sunlight - Store with lid tightly closed

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Purified water, Caprylic/Capric Triglycerides, Butyrospermum Parkii (Shea) butter, Cetearyl alcohol, polysorbate 60, Glyceryl stearate, Cyclopentasiloxane, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, me, Extract of Aloe Barbadense leaves, Extract of arnica,
Acrylamide/Sodium Acrylate Copolymer, Mineral Oil, Trideceth-6 Tocopheryl acetate, triethanol amine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ReleafPEAK label 100mlReleafPEAK label 100ml

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78663-211-342025-01-30C16284748780-12cef2736-97b2-d83d-e063-dadaa90ab31fRELEAF TECHNOLOGIES (as PLD) - ReleafPEAK (78663-211)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78663-211-34ReleafPEAK HemCareMAXIMUM RELIEF100 mL in 1 TUBELOTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78663-211RELEAFPEAK HEMCARE MAXIMUM RELIEF (LIDOCAINE, MENTHOL) LOTION [RELEAF TECHNOLOGIES LLC]11 package rows20231110_09c0b3ec-2857-7dbd-e063-6294a90a8052.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78663-21178663-211-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
TRIDECETH-63T5PCR2H0CIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WATER059QF0KO0RIACT
HEMPTD1MUT01Q7IACT
SHEA BUTTERK49155WL9YIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANAO80TY208ZWIACT
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)M4PPW69Y4HIACT
MINERAL OILT5L8T28FGPIACT
CYCLOMETHICONE 50THT5PCI0RIACT

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
09c0c2e2-4b2c-0066-e063-6394a90acfdb09c0b3ec-2857-7dbd-e063-6294a90a80522023-11-08WarningsExact identifier
spl id: 09c0c2e2-4b2c-0066-e063-6394a90acfdb
spl set id: 09c0b3ec-2857-7dbd-e063-6294a90a8052

Reported adverse events (FAERS/openFDA)#

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