Label: CBD PAIN CREAM- lidocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 10, 2019

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  • Active Ingredient

    Lidocaine 4%

  • Purpose

    Topical analgesic

  • Uses

    Temporarily relieves minor pain associated with:

    .Arthritis         .Sprains            .Simple backache

    .Bruises       .Muscle strains      .Cramps

  • Warnings

    For external use only

    When using this product

    • Use only as directed, do not bandage tightly, avoid contact with eyes, do not apply to wounds or damaged skin, do not use in large quantities, particularly over raw surfaces or blistered areas.

    Stop use and ask a doctor if

    • condition worsens, symptoms persist for more than 7 days or symptoms clear up and occur again within a few days.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.
    • Children under 12 years of age : Consult a doctor
  • STORAGE AND HANDLING

  • Inactive ingrdients

    Allantoin, Caprylic/Capric Triglyceride, Capsicum Annuum Fruit Powder, Calcium Disodium EDTA, Cannabis Sativa Extract Oil, Dimethicone, dI-alpha Tocopheryl Acetate, Ethyl Alcohol, Ethylhexylglycerin, Ethylhexyl Sterate, Fragrance, Glycerin, Phenoxyethanol, Polysorbate 80, Propanediol, Propylene Glycol, Purified Water, Simethicone, Sodium Polyacrylate, Trideceth-6, Vitis Vinifera (Grape) Seed oil, Xanthan Gum.

  • QUESTIONS

  • Principal Display Panel

    NDC 73332-001-01

    FOR EXTERNAL USE ONLY

    CBD Pain Cream

    + Lidocaine

    Label

  • INGREDIENTS AND APPEARANCE
    CBD PAIN CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73332-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    PAPRIKA (UNII: X72Z47861V)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    CANNABIS SATIVA SEED (UNII: QE567Z26NG)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73332-001-0174 mL in 1 TUBE; Type 0: Not a Combination Product09/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34609/18/2019
    Labeler - NATURES ORGANICS LLC (117141162)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ion Labs Inc106499791manufacture(73332-001)
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