Hemp Theory ® Fast Acting Pain Cream

Manufacturer
Clientele, Inc.
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:57

Label at a glance#

ProductHemp Theory Fast Acting Pain
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Dosage and administration

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age, consult a Physician.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 2%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Indications

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with:

Arthritis / Simple backache / Strains / Sprains / Bruises.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a Physician.

Do not apply to wounds or damaged skin.

Do not bandage tightly.

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 2 years of age and older:
apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age, consult a Physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Cetyl Alcohol, Isopropyl Myristate, Stearic Acid, Glycol Stearate SE, Hemp Extract, Beta-Cyclodextrin, Polysorbate 80, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Acetyl Glucosamine, Dimethyl Sulfone, Pyridoxine HCl, Arnica Montana Flower Extract, Hydroxymethoxphenyl Decanone, Tocopheryl Acetate, Curcuma Longa (Turmeric) Root Extract, Calendula Officinalis Flower Extract, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Polydecene, Laureth-8, Astaxanthin, Carbomer, Disodium EDTA, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: HonestCeuticals LLC,
Steamboat Springs CO 80487

PRINCIPAL DISPLAY PANEL - 89 ml Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEMP®
THEORY

FAST-ACTING
PAIN
CREAM

+NANO
HEMP EXTRACT
2400 MG

nanobidiol®

3 fl oz / 89 ml

PRINCIPAL DISPLAY PANEL - 89 ml Tube
PRINCIPAL DISPLAY PANEL - 89 ml Tube

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64483-492-032021-01-29C16284748780-1ba0f9c33-49c8-a910-e053-dadaa90a0b85Hemp Theory ® Fast Acting Pain Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64483-492-03Hemp Theory Fast Acting Pain89 mL in 1 TUBECREAM891

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64483-492HEMP THEORY FAST ACTING PAIN (MENTHOL, UNSPECIFIED FORM) CREAM [CLIENTELE, INC.]1Legacy NDC, 1 package rows20191212_06668270-15b9-4343-be10-a3401a2d976c.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64483-49264483-492-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

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
9bddd80c-5e61-42f5-89c5-50bd8677f2e606668270-15b9-4343-be10-a3401a2d976c2019-12-09WarningsExact identifier
spl id: 9bddd80c-5e61-42f5-89c5-50bd8677f2e6
spl set id: 06668270-15b9-4343-be10-a3401a2d976c

Reported adverse events (FAERS/openFDA)#

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