Label: FORMULA 4 PAIN- lidocaine hcl, menthol gel

  • NDC Code(s): 58292-004-01
  • Packager: Lifequest Creations 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 3, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients                Purpose

    Lidocaine HCl 4%                  Topical Anesthetic

    Menthol 1%                          Topical Analgesic

  • PURPOSE

  • Uses

    Fast Pain Relief

  • Warnings

    FOR EXTERNAL USE ONLY. NOT INTENDED FOR INGESTION DONT USE ONLARGE AREAS OF THE BODY OR ON CUT, IRRITATED OR SWOLLEN SKIN. Use only as directed, avoid contact with eyes and mucus membranes If pregnant or breast-feeding, ask a health care professional before use. If swallowed, get medical help

  • KEEP OUT OF REACH OF CHILDREN

  • Direction

    Apply topically to area. 

  • Inactive ingredients

    Purified water, Arnica, EMU OIL, MCT OIL, Hemp seed oil, Glyceryl stearate, Cetearyl Alcohol, Copaiba, Tea Tree, Basil, Rosemary, Rose, Lavender, Ginger, Capsicum, Bergamot

  • Other information

    Great for : Sore muscles, aching joints, gout flare-ups and body pain and other sports related pain.

    Menthol crystals gives instant cooling and pain releif. Physician formulated (roll-on-blend) glides on is non-sticky, and absorbs quickly.

    Arnica reduces bruising and swelling. Lidocaine helps alleviate stiffness, inflammation, joint pain, muscle soreness and more. Hemp seed oil

    allows ingredients to cross and absorb into the skin. With its healing properties, Emu oil reduces fibrosis from skin damage caused by radiation

    therapy.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    FORMULA 4 PAIN 
    lidocaine hcl, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58292-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    EMU OIL (UNII: 344821WD61)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COPAIBA OIL (UNII: 64VX45Y68N)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    BASIL OIL (UNII: Z129UMU8LE)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    ROSE OIL (UNII: WUB68Y35M7)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    CAPSICUM OLEORESIN (UNII: UW86K581WY)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58292-004-0189 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/22/2023
    Labeler - Lifequest Creations LLC (053654857)
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