Label: HEMP THEORY FAST ACTING PAIN- menthol, unspecified form cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 9, 2019

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  • 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

    PRINCIPAL DISPLAY PANEL - 89 ml Tube
  • INGREDIENTS AND APPEARANCE
    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)
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