FDA.reportPublic FDA data

CBDaF CBD & Lidocaine Topical Gel

Manufacturer
Prime Enterprises
Effective date
2020-10-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:07

Label at a glance#

ProductCBDaF Topical Gel
Active ingredientMENTHOL, LIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

Use for temporary relief of minor pain

Dosage and administration

Adults and children over 12 years: apply a thin layer to affected area every 6 to 8 hours, but no more than 3 to 4 times daily if product comes in contact hands, wash hands with soap and water children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 4%, Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Use for temporary relief of minor pain

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

On large areas of the body or on cut, irritated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

When using this product

OTC - WHEN USING SECTION

Use only as directed

Avoid contact with eyes and mucous membranes

Do not apply to skin folds

Do not apply to wounds or damaged, broken or irritated skin

Do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

Stop use and ask doctor if

OTC - STOP USE SECTION

condition worses

irriation develops

redness appears

symptoms persist for more than 7 days or clear up and occurs again within a few days

Kepp 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.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

apply a thin layer to affected area every 6 to 8 hours, but no more than 3 to 4 times daily

if product comes in contact hands, wash hands with soap and water

children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylamide/Sodium Acrylate Copolymer, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Arnica Montana Flower Extract, Borago Officinalis Seed Oil, Boswellia Serrata Extract, Camellia Oleifera (Green Tea) Leaf Extract, Cannabidiol, Chamomilla Recutita (Matricaria) Flower Extract, Curcuma Longa (Turmeric) Root Extract, Glycerin, Harpagophytum Procumbens Root Extract, Mentha Piperita (Peppermint) Oil, Mineral Oil, Oenothera Biennis (Evening Primrose) Oil, Polysorbate 20, Propylene Glycol, Ribes Nigrum (Black Currant) Fruit Extract, Salix Alba (White Willow) Bark Extract, SD Alcohol 40-B, Sodium Hydroxide, Trideceth-6, Water

Questions and comments

SPL UNCLASSIFIED SECTION

480.562.6282

CBDaF CBD & lidocaine Topical Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

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
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0366-32023-01-30C16284748780-1f386c649-beed-0266-e053-dadaa90a7c1aCBDaF CBD & Lidocaine Topical Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0366-3CBDaFTopical Gel89 mL in 1 BOTTLEGEL891

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0366CBDAF TOPICAL GEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [PRIME ENTERPRISES]1Legacy NDC, 1 package rows20201021_b1940679-80d7-64c2-e053-2995a90ac530.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-036658443-0366-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLAMIDE20R035KLCIIACT
SODIUM ACRYLATE7C98FKB43HIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
WATER059QF0KO0RIACT
TRIDECETH-63T5PCR2H0CIACT
MENTHOLL7T10EIP3AACTIB
CHAMOMILEFGL3685T2XIACT
MINERAL OILT5L8T28FGPIACT
SODIUM HYDROXIDE55X04QC32IIACT
HORSE CHESTNUT3C18L6RJAZIACT
PEPPERMINT OILAV092KU4JHIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
HARPAGOPHYTUM PROCUMBENS ROOT1OYM338E89IACT
SALIX ALBA BARK205MXS71H7IACT
BORAGE SEED OILF8XAG1755SIACT
TURMERIC856YO1Z64FIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
PROPYLENE GLYCOL6DC9Q167V3IACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
BLACK CURRANT9755T40D11IACT
ALCOHOL3K9958V90MIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
POLYSORBATE 207T1F30V5YHIACT
CANNABIDIOL19GBJ60SN5IACT
GLYCERINPDC6A3C0OXIACT

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
b194068d-76df-2191-e053-2a95a90adf19b1940679-80d7-64c2-e053-2995a90ac5302020-10-13WarningsExact identifier
spl id: b194068d-76df-2191-e053-2a95a90adf19
spl set id: b1940679-80d7-64c2-e053-2995a90ac530

Reported adverse events (FAERS/openFDA)#

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