FDA.reportPublic FDA data

Premium HEMP Pain Relief

Manufacturer
Sambria Pharmaceuticals Inc.
Effective date
2021-07-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:22

Label at a glance#

ProductPremium HEMP Pain Relief
Active ingredientLIDOCAINE, MENTHOL
Label structure8 sections

Indications and uses

For temporary relief of pain and itching due to minor skin irritation.

Dosage and administration

For adults and children two-years or older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4.0%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching due to minor skin irritation.

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes

Do not use 

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if

OTC - STOP USE SECTION

Condition worsens or, if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children two-years or older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine, Full Spectrum Hemp Extract

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

FDA Registered: NDC No. 54723 info@sambriapharma.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
54723-201-002023-01-30C16284748780-1f386c649-a674-0266-e053-dadaa90a7c1aPremium HEMP Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54723-201-00Premium HEMP Pain Relief113 g in 1 BOTTLECREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54723-201PREMIUM HEMP PAIN RELIEF (LIDOCAINE, MENTHOL) CREAM [SAMBRIA PHARMACEUTICALS INC.]2Legacy NDC, 1 package rows20210713_9c1a5a43-6f07-444c-e053-2995a90ab0a0.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54723-20154723-201-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
EMU OIL344821WD61IACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
LAURETH-7Z95S6G8201IACT
TEA TREE OILVIF565UC2GIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB

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
c6ed95c3-70fd-1fec-e053-2995a90aa9a79c1a5a43-6f07-444c-e053-2995a90ab0a02021-07-12WarningsExact identifier
spl id: c6ed95c3-70fd-1fec-e053-2995a90aa9a7
spl set id: 9c1a5a43-6f07-444c-e053-2995a90ab0a0

Reported adverse events (FAERS/openFDA)#

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