Label: PAINPATROL CBD PAIN RELIEF (camphor- synthetic 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 12, 2019

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Camphor (5.0%)

  • Purpose

    External Analgesic

  • Uses

    Temporarily relieves foot, ankle and leg pain associated with:

    • arthritis
    • muscle aches
    • muscle strains
    • joint pain
  • Directions

    Use only as directed

    • Do not use on children under 12 years of age.
    • Apply onto affected area no more than four times daily.
  • Warnings

    For external use only: Flammable: Keep away from excessive heat or open flame.

    • Ask a doctor before use if you have sensitive skin or if you are taking any blood thinners.

    When using this product

    Do not use on wounds or irritated skin

    • Do not bandage tightly or use with a heating pad
    • Wash hands after use with cool water

    • If pregnant or breast feeding, ask a health professional before use

    • Keep out of reach of children. If accidentally swallowed, contact a doctor or poison control center immediately

    • Stop use and ask a doctor if condition worsens or if pain persists for more than 7 days, or clears up, then reoccurs within a few days.
  • Inactive Ingredients

    Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Aescin (Horse Chestnut Extract), Aloe Vera, Arnica Montana Extract, C12-15 Alkyl Benzoate, Chondroitin Sulfate, Diazodinyl Urea, Dimethicone, Disodium EDTA, dl Panthenol, Fructoborate, Cannabis Sativa Oil (Hemp Derived), Glucosamine Sulfate, Glycerin, Glycerol Stearate, Hydroxypropyl methylcellulose, Iodopropynyl Butylcarbamate, Methyl Gluceth-20, Methyl Glucose Sesquistearate, Peppermint Oil, Polysorbate 20, Potassium Carbomer, Purified Water, Shea Butter, Tocopheryl Acetate, Trolamine Salicylate

  • Other Information

    Questions or comments? Call (877) 383-2334.

    Store in a cool dry place with the cap tightly closed. Note: Because this product contains natural ingredients, color may vary.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    SmartScience Laboratories, Inc.
    13760 Reptron Blvd., Tampa, FL 33626

  • PRINCIPAL DISPLAY PANEL - 114 g Jar Label

    PainPatrol™
    CBD

    • ORGANIC HEMP OIL •
    100% NATURAL

    THC Free

    Pain Relief Cream

    200mg CBD
    Net Wt 4 oz. (114g)

    Deep Dermal Delivery Technology™

    PRINCIPAL DISPLAY PANEL - 114 g Jar Label
  • INGREDIENTS AND APPEARANCE
    PAINPATROL CBD PAIN RELIEF 
    camphor (synthetic) cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64479-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Methyl Glucose Sesquistearate (UNII: V1YW10H14D)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CALCITRIOL (UNII: FXC9231JVH)  
    CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Escin (UNII: RUU8G67GQM)  
    GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Methyl Gluceth-20 (UNII: J3QD0LD11P)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    Shea Butter (UNII: K49155WL9Y)  
    Sorbitan Monolaurate (UNII: 6W9PS8B71J)  
    Trolamine Salicylate (UNII: H8O4040BHD)  
    Cannabidiol (UNII: 19GBJ60SN5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64479-202-11114 g in 1 JAR; Type 0: Not a Combination Product10/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34810/17/2019
    Labeler - SmartScience Laboratories, Inc. (035907919)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!