Label: POMG PAIN RELIEF ROLLER- lidocaine hydrochloride, menthol gel

  • NDC Code(s): 84615-004-02, 84615-004-03
  • Packager: POMG LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 27, 2024

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  • Active Ingredients

    Lidocaine HCl 4%

    Menthol 5%

  • Purpose

    Lidocaine HCl 4% ……….…Topical Anesthetic

    Menthol 5% ………………... Pain Relief

  • Use

    • For temporary relief of pain in muscles, joints, and tendons
  • Warnings

    For external use only

    Do not use

    • If you are allergic to any ingredients in this product

    • On open sores and wounds

    • In large quantities

    When using this product

    • Use only as directed

    • Do not bandage tightly

    • Avoid contact with eyes and other mucous membranes

    • Do not expose the area to external heat or direct sunlight

    Stop use and consult a doctor if

    • Conditions worsen or symptoms persist for more than 7 days

    • Symptoms clear up and occur again within a few days

    • Redness is present or excessive skin irritation occurs

    • You experience severe burning pain, swelling, or blistering where product was applied

    • Allergic reaction occurs

    • If pregnant or breast-feeding, consult a doctor before use

    • Keep out of reach of children and pets. If swallowed, get medical help or contact Poison Control Center right away

  • Directions

    • Adults and children 12 years of age and older:

    rub a thin film over desired area not more than 3 to 4 times daily

    • Children under 12 years of age: consult a doctor

    • Wash hands after use with soap and water

  • INACTIVE INGREDIENT

    reverse osmosis water, organic aloe juice, magnesium chloride flakes, msm (methylsulfonylmethane), hydroxypropyl starch phosphate, organic arnica (co2 extract), organic calendula (co2 extract), organic capsicum (co2 extract)

  • PRINCIPAL DISPLAY PANEL

    Menthol 5% Lidocaine 4%

    P.O.M.G

    Pharmaceutical Organic Medicine Group

    Pain Relief Roller

    Maximum Strength Lidocaine

    Without a Prescription

    Made with Organic Ingredients

    Quick Drying

    Instantly Relieves Pain

    Net Wt. 3 OZ (90mL)

    1

    2

    3

  • INGREDIENTS AND APPEARANCE
    POMG PAIN RELIEF ROLLER 
    lidocaine hydrochloride, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84615-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)  
    PAPRIKA (UNII: X72Z47861V)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84615-004-0390 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product08/14/2024
    2NDC:84615-004-021 in 1 CARTON08/14/2024
    259 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/14/2024
    Labeler - POMG LLC (119126509)
    Establishment
    NameAddressID/FEIBusiness Operations
    POMG LLC119126509manufacture(84615-004)
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