Label: GREEN COMPASS REDUCE TOPICAL PAIN- camphor, menthol, methyl salicylate 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 January 1, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Camphor 3%

    Menthol 10%

    Methyl Salicylate 10%

  • PURPOSE

    Purpose

    Topical Analgesic

    Topical Analgesic

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    For temporary relief of minor aches and pains of muscles and joints.

  • WARNINGS

    Warnings

    For external use only.

    Do not use

    • on wounds or damaged skin
    • with a heating pad

    When using this product

    • avoid contact with the eyes
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days
    • condition clears up and occurs again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients

    butyrospermum parkii (shea) butter, caprylhydroxamid acid, caprylic capric triglyceride, CBD hemp extract, cetearyl alcohol, cetearyl glucoside, citric acid, glycerin, glyceryl caprylate, glyceryl stearate citrate, organic aloe barbadensis (aloe vera) leaf juice, organic arnica extract, organic cinnamon leaf essential oil, organic hemp oil, organic horsetail oil, organic rosmarinum officinalis (rosemary) leaf extract, organic tapioca starch modified, sodium ascorbyl phosphate, turmeric extract, water (aqua), xanthan gum.

  • SPL UNCLASSIFIED SECTION

    LEARN MORE AT

    GreenCompassGlobal.com

    DISTRIBUTED BY:

    Green Compass, Inc.

    1121 Military Cutoff Rd., Ste C339

    Wilmington, NC 28405 USA

  • PRINCIPAL DISPLAY PANEL

    REDUCE

    TOPICAL PAIN CREAM

    WITH 300 mg FULL SPECTRUM HEMP FLOWER EXTRACT

    GREEN COMPASS

    1.7 FL OZ (50 mL)

    73132-001-50 FINAL

  • INGREDIENTS AND APPEARANCE
    GREEN COMPASS REDUCE TOPICAL PAIN 
    camphor, menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73132-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3 g  in 100 mL
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
    EQUISETUM ARVENSE WHOLE (UNII: 73DM367W4P)  
    TURMERIC (UNII: 856YO1Z64F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HEMP (UNII: TD1MUT01Q7)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ROSEMARY (UNII: IJ67X351P9)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73132-001-501 in 1 CARTON07/24/2019
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/24/2019
    Labeler - Green Compass, Inc. (105963322)
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