FDA.reportPublic FDA data

BAKER'S BEST Pain Relief Cream with Pure Hemp Seed Oil

Manufacturer
BAKER'S BEST HEALTH PRODUCTS, INC.
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:04

Label at a glance#

ProductBAKERS BEST Pain Relief with Pure Hemp Seed Oil
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure7 sections

Indications and uses

For the temporary relief of pain, and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.

Dosage and administration

Apply a thin layer to affected area not more than 3 to 4 times in 24 hours. Adults and children over 12 years: consult a doctor before use. Children under 12 years:

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl (4.00%)

Menthol (1.00%)

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain, and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.

Warnings:

WARNINGS SECTION

For external use only

Use only as directed

Do not use

OTC - DO NOT USE SECTION

  • in large quantities, over raw skin or blistered areas.
  • Avoid contact with eyes. 
  • If symptoms worsen or persist for more than 7 days, then discontinue use and consult a doctor.
  • Do not bandage or apply local heat to area of use.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • ask a doctor before use,

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer to affected area not more than 3 to 4 times in 24 hours. Adults and children over 12 years:

consult a doctor before use. Children under 12 years:

Additional Information:

SPL UNCLASSIFIED SECTION

  • Store at room temperature.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cannabis Sativa (Hemp) Seed Oil, Cetyl Alcohol, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Methylsulfonylmethane (MSM), Methyl Salicylate, PEG-8, Phenoxyethanol, Polyacrylamide, Polysorbate-80, Triethanolamine.

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
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76102-389-00BAKERS BEST Pain Relief with Pure Hemp Seed Oil56.7 g in 1 JARCREAM56.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76102-389BAKERS BEST PAIN RELIEF WITH PURE HEMP SEED OIL (LIDOCAINE HYDROCHLORIDE, MENTHOL) CREAM [BAKER'S BEST HEALTH PRODUCTS, INC.]2Current NDC, 1 package rows20231106_ae54c234-bfe4-4a74-b293-db7efda7884b.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76102-38976102-389-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CETYL ALCOHOL936JST6JCNIACT
EMU OIL344821WD61IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LAURETH-7Z95S6G8201IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
METHYL SALICYLATELAV5U5022YIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
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
BAKERS BEST Pain Relief with Pure Hemp Seed OilLIDOCAINE HYDROCHLORIDE, MENTHOLBAKER'S BEST HEALTH PRODUCTS, INC.ae54c234-bfe4-4a74-b293-db7efda7884b2023-11-06WarningsExact identifier
ndc (package): 76102-389-00
ndc (product): 76102-389
ndc11 (package): 76102038900
spl id: 0975c654-f32e-1c35-e063-6394a90a0ba2
spl set id: ae54c234-bfe4-4a74-b293-db7efda7884b

Reported adverse events (FAERS/openFDA)#

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