Label: PAIN RELIEF CAFFEINE AND HEMP (caffeine (coffeinum) 6x, hemp extract- cannabis sativa 2x spray

  • NDC Code(s): 73002-321-01
  • Packager: Green Earth Health Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated August 27, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredients                                                                                            Purpose

    Caffeine (Coffeinum) 6X (0.0018mg) HPUS                                                 Analgesic
    Hemp extract (Cannabis sativa) 2X (11.3 mg) HPUS                                    Anti-inflammatory

    Approximately 158 sprays per container

    Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

  • PURPOSE

  • Indication:

    Temporarily relieves pain associated with sciatica, lower back pain and cystitis

  • KEEP OUT OF REACH OF CHILDREN

  • Warnings:

    • Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
    • If symptoms persist or worsen, stop using this product and consult physician.
    • Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention.
    • If pregnant or breastfeeding or if diagnosed with psychiatric or mood disorder, seek medical advice before use.
    • Keep out of reach of children.

  • Directions For Use:

    • Do not use if tamperproof cover is missing
    • Press down 4 times to prime the pump.
    • Spray 2 times directly into the mouth or under the tongue.
    • Start using 3 times per day. Use as needed thereafter to relieve discomfort.
    • Allow several days for product to take maximum effect.
    • Use within 60 days from opening. Store at 50° to 75°F (10°C to 24°C)
  • Other Information:

    • Consult a medical professional if using other medications for known interactions.
    • Cannabidiol in hemp extract may alter the metabolism of other drugs.
  • Inactive Ingredients:

    Citric acid, flavoring, glycerin, potassium sorbate,purified water, sodium benzoate, vitamin C, xanthan gum

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF CAFFEINE AND HEMP 
    caffeine (coffeinum) 6x, hemp extract (cannabis sativa) 2x spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73002-321
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE CITRATE (UNII: U26EO4675Q) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE CITRATE6 [hp_X]  in 1 mL
    CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP (UNII: 8X454SZ22D) (CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP - UNII:8X454SZ22D) CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP2 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)  
    TEA LEAF (UNII: GH42T47V24)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73002-321-0128 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/19/2019
    Labeler - Green Earth Health Inc. (116983264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Maitland Labs of Central Florida080974960manufacture(73002-321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Organics Corporation of America DBA Ambix Laboratories061061164manufacture(73002-321)