Label: DIOLPURE MENTHOL PAIN RELIEF CREAM- menthol, camphor 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 ingredients

    Menthol USP 12%

    Camphor 6%

  • Purpose

    Menthol USP 12%.....................Topical Analgesic

    Camphor 6%.............................Topical Analgesic

  • Uses

    for temporary relief of minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
  • Warnings

    For external use only

    Do not use

    • on damaged or broken skin

    When using this product

    • do not bandage tightly
    • avoid contact with eyes

    Stop use and ask doctor if

    • condition worses or persists
    • rash develops

    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 not more than 3 to 4 times daily
    • Children under 12 years of age: Consult a doctor
  • Other information

    • Store in a cool, dry place
    • Avoid direct sunlight
  • Inactive ingredients

    Arnica Montana, Calendula Officinalis, Cannabidiol, Carbomer, Citric Acid, Ethyl Alcohol, Methyl Glucose Dioleate, Methylsulfonylmethane (MSM), Organic Medium-Chain Triglyceride (MCT), Coconut Oil, Purified Water, Sodium Hydroxide

  • PRINCIPAL DISPLAY PANEL

    DiolPure

    Menthol 12%

    Pain Relief Cream

    500MG CBD to moisturize skin

    Menthol 12%

    For temporary relief of minor aches and pains

    Net Wt. 2 oz (56.7 g)

    1

    2

  • INGREDIENTS AND APPEARANCE
    DIOLPURE MENTHOL PAIN RELIEF CREAM 
    menthol, camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82093-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)6 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    WATER (UNII: 059QF0KO0R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82093-001-011 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(82093-001)
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