Label: DIOLPURE LIDOCAINE PAIN RELIEF CREAM- lidocaine hcl 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 July 9, 2021

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  • Active ingredient

    Lidocaine HCL 4%

  • Purpose

    Lidocaine HCL 4%.................Topical Anesthetic

  • Uses

    for temporary relief of minor joint and muscle pain

  • Warnings

    For external use only

    Do not use

    • on large areas of the body or on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor

    When using this product

    • use only as directed
    • do not allow contact with the eyes
    • do not bandage or apply local heat (such as heating pads) to the area of use

    Stop use and ask doctor if

    • condition worsens
    • symptoms persist for more than 7 days

    If pregnant or breastfeeding, consult your doctor 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 every 6 to 8 hours, do not exceed 3 to 4 applications in a 24 hour period
    • Before and after applying, wash hands with soap and water
    • Children under 12 years of age: Consult a doctor
  • Other information

    • store in a cool, dry place
    • avoid direct sunlight
  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Cannabidiol, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ethylhexylglycerin, Methyl Glucose Dioleate, Organic Medium-Chain Triglyceride (MCT), Coconut Oil, Purified Water, Sodium Hydroxide

  • PRINCIPAL DISPLAY PANEL

    DiolPure

    Lidocaine 4%

    Pain Relief Cream

    Uscented

    500MG CBD to moisturize skin

    Lidocaine 4%

    For temporary relief of minor joint and muscle pain

    Net Wt. 2 oz (56.7 g)

    1

    2

  • INGREDIENTS AND APPEARANCE
    DIOLPURE LIDOCAINE PAIN RELIEF CREAM 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82093-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    WATER (UNII: 059QF0KO0R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82093-002-011 in 1 CARTON07/01/2021
    156.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2021
    Labeler - DiolPure, LLC (118147963)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioLyte Laboratories, LLC015560564manufacture(82093-002)
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