Label: CBD MEDIC - ODOR-FREE SERIOUS RELIEF- lidocaine hcl cream

  • Category: HUMAN OTC DRUG LABEL

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 April 3, 2017

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  • Active Ingredient

    Lidocaine HCL 4%

  • Purpose

    Lidocaine HCL - External Analgesic

  • Uses

    Temporarily relieves minor pain.

  • Warnings

    For external use only. Do not use on wounds or damaged skin. When using this product - avoid contact with eyes or mucous membranes - do not bandage tightly or use with heating pad. Stop use and ask a doctor if - condition worsens or symptoms persist for more than 7 days - symptoms clear up and occur again within a few days - excessive skin irritation develops.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • 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 Ingredients

    Beeswax (organic), cotton seed oil, emulsifying wax, hemp extract, jojoba seed oil, magnesium oxide, purified water, shea butter, silver oxide, sorbic acid, zinc oxide.

  • PRINCIPAL DISPLAY PANEL - 30g Size

    CBDMEDIC

    ODOR-FREE
    SERIOUS RELIEF
    Revolutionary Pain Relief
    Lidocaine 4%

    Net WT 30g (1oz.)

    Tube

  • INGREDIENTS AND APPEARANCE
    CBD MEDIC - ODOR-FREE SERIOUS RELIEF 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-721
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COTTONSEED OIL (UNII: H3E878020N)  
    HEMP (UNII: TD1MUT01Q7)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-721-3030 g in 1 TUBE; Type 0: Not a Combination Product04/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/03/2017
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-721) , label(24909-721)