Label: PAINPATROL CBD PAIN RELIEF WITH LIDOCAINE- lidocaine hydrochloride 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 February 19, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Lidocaine (4.0%)

  • Purpose

    Topical Anesthetic

  • Warnings

    For external use only:

    Allergy Alert

    If prone to allergic reaction from aspirin or salicylates, consult your doctor.

  • When using this product

    Use only as directed. Do not bandage tightly or use with a heating pad. Avoid contact with eyes or mucous membranes. Do not apply to wounds or damaged skin.

  • PREGNANCY OR BREAST FEEDING

    • If pregnant or breast feeding, ask a health professional before use
  • KEEP OUT OF REACH OF CHILDREN

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

    • Stop use and ask a doctor if condition worsens or symptoms persist for more than seven days -or- clear up and occur within a few days. Redness is present. Irritation develops.
  • Directions

    Adults and children over 12 years of age: Apply generously to affected area. Massage into painful area until thoroughly absorbed into skin. Repeat as necessary, but no more than 4 times a day. Children 12 years or younger, ask a doctor.

  • Inactive Ingredients

    Aloe Vera, Acrylates/C10-30 Alkyl Acrylate, Allantoin, Avocado Oil , Cetearyl Alcohol, Diazolidinyl Urea, Dimethicone, Disodium EDTA, Evening Primrose Oil, Glycerin, Glycerol Stearate, Cannabis Sativa Extract (Hemp Derived), Iodopropynyl Butylcarbamate, Mineral Oil, Perilla Oil, Polysorbate 80, Purified Water, Stearic Acid, Tocopheryl Acetate, Triethanolamine.

  • 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

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

  • PRINCIPAL DISPLAY PANEL - 57 g Jar Label

    PainPatrol™
    CBD

    200mg CBD Net Wt 2 oz. (57g)

    Pain Relief Cream
    with Lidocaine

    ODOR
    FREE

    Deep Dermal Delivery Technology™

    Principal Display Panel - 57 g Jar Label
  • INGREDIENTS AND APPEARANCE
    PAINPATROL CBD PAIN RELIEF WITH LIDOCAINE 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64479-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Allantoin (UNII: 344S277G0Z)  
    Avocado Oil (UNII: 6VNO72PFC1)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Evening Primrose Oil (UNII: 3Q9L08K71N)  
    Glycerin (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Cannabidiol (UNII: 19GBJ60SN5)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Perilla Frutescens Seed Oil (UNII: 322MS57V7Z)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64479-203-1257 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)
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