Label: CBD CLINIC PAIN RELIEF - LEVEL 1- lidocaine hcl cream

  • NDC Code(s): 24909-761-20, 24909-761-44
  • Packager: Aidance Skincare & Topical Solutions, LLC
  • 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 July 11, 2016

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

  • Active Ingredients

    Lidocaine HCL USP, 4%

  • Purpose

    Lidocaine HCL - Topical Anesthetic

  • Uses

    temporarily relieves minor aches and pain of muscles and joints

  • 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 a heating pad
    Stop use and ask a doctor if
    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation develops
    If pregnant or breast-feeding
    ask a health professional before use
    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
    Wash hands with soap and water after use (unless applying to hands)
    • children under 12 years of age: ask a doctor

  • Inactive Ingredients

    beeswax, CBD hemp oil, cottonseed oil, emulsifying wax, jojoba seed oil, purified water, shea butter, sorbic acid

  • Questions?

    Call 1-888-422-3254

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    CBD CLINIC PAIN RELIEF - LEVEL 1 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-761
    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
    COTTONSEED OIL (UNII: H3E878020N)  
    HEMP (UNII: TD1MUT01Q7)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-761-4444 g in 1 JAR; Type 0: Not a Combination Product10/01/2019
    2NDC:24909-761-20200 g in 1 JAR; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2019
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-761) , label(24909-761)