HEMP THEORY FAST ACTING PAIN- menthol, unspecified form cream

Hemp Theory by

Drug Labeling and Warnings

Hemp Theory by is a Otc medication manufactured, distributed, or labeled by Clientele, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

HEMP THEORY   FAST ACTING PAIN
menthol, unspecified form cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64483-492
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64483-492-03	89 mL in 1 TUBE; Type 0: Not a Combination Product	03/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/19/2019

Labeler - Clientele, Inc. (085021806)