HEMP THEORY  FAST ACTING PAIN- menthol, unspecified form cream 
Clientele, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hemp Theory®
Fast Acting Pain Cream

Drug Facts

Active Ingredients

Menthol 2%

Purpose

Topical analgesic

Indications

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

Arthritis / Simple backache / Strains / Sprains / Bruises.

Warnings

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.

Keep out of reach of children.

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

Directions

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

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.

DISTRIBUTED BY: HonestCeuticals LLC,
Steamboat Springs CO 80487

PRINCIPAL DISPLAY PANEL - 89 ml Tube

HEMP®
THEORY

FAST-ACTING
PAIN
CREAM

+NANO
HEMP EXTRACT
2400 MG

nanobidiol®

3 fl oz / 89 ml

PRINCIPAL DISPLAY PANEL - 89 ml Tube
HEMP THEORY   FAST ACTING PAIN
menthol, unspecified form cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64483-492
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Glycol Stearate SE (UNII: 6YLY96TQL6)  
APOCYNUM CANNABINUM ROOT (UNII: 2F92409L9Z)  
BETADEX (UNII: JV039JZZ3A)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
COCONUT OIL (UNII: Q9L0O73W7L)  
N-ACETYLGLUCOSAMINE (UNII: V956696549)  
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TURMERIC (UNII: 856YO1Z64F)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
C20-40 PARETH-3 (UNII: 68103A23TQ)  
Astaxanthin (UNII: 8XPW32PR7I)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64483-492-0389 mL in 1 TUBE; Type 0: Not a Combination Product03/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/19/2019
Labeler - Clientele, Inc. (085021806)

Revised: 12/2019
Document Id: 9bddd80c-5e61-42f5-89c5-50bd8677f2e6
Set id: 06668270-15b9-4343-be10-a3401a2d976c
Version: 1
Effective Time: 20191209
 
Clientele, Inc.