Label: POMG PAIN RELIEF BODY- lidocaine cream

  • NDC Code(s): 84615-005-05, 84615-005-06
  • Packager: POMG LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 27, 2024

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  • Active Ingredient

    Lidocaine USP 4%

  • Purpose

    Lidocaine USP 4%................ Topical Anesthetic

  • Use

    • For temporary relief of pain in muscles, joints, and tendons. Can also be used for minor burns and bug bites

  • 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

    • Avoid contact with eyes and other mucous membranes

    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 with 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

    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

    • If using on hands, avoid contact with eyes and mouth

  • Inactive Ingredients

    Organic shea butter, organic mango butter, organic cocoa butter (unscented), organic beeswax, organic argan oil, organic grapeseed oil, organic sweet almond oil, organic jojoba oil, organic apricot oil, organic avocado oil, organic hemp seed oil, organic rosehip oil, organic arnica montana (co2 extract)

    Allergy Information: This product contains tree nuts (almond, argan, ad apricot kernel)

  • PRINCIPAL DISPLAY PANEL

    Lidocaine 4%

    P.O.M.G.

    Pharmaceutical Organic Medicine Group

    Pain RElief

    Body Cream

    Organic

    Maximum Strength Lidocaine Without a Prescription

    For All Skin Types

    Net Wt. 6oz

    1

    2

    3

    4

  • INGREDIENTS AND APPEARANCE
    POMG PAIN RELIEF BODY 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84615-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    ACEPROMAZINE (UNII: 54EJ303F0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84615-005-06170 g in 1 JAR; Type 0: Not a Combination Product08/14/2024
    2NDC:84615-005-05142 g in 1 JAR; Type 0: Not a Combination Product08/14/2024
    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(84615-005)
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