Label: PERFORMANCE BRANDS STEEL RELEAF PAIN RELIEVING LIQUID- lidocaine hydrochloride, menthol liquid

  • NDC Code(s): 58443-0268-3
  • Packager: Prime Enterprises, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 September 28, 2022

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  • Active Ingredients

    Lidocaine Hydrochloride 4%

    Menthol 1%

  • Purpose

    Topical Analgesic

  • Uses

    For temporary relief of pain

  • Warnings

    For external use only

    Do not use

    • More than one recommended dose at a time
    • On broken or irritated skin
    • If you are allergic to any ingredients of this product
    • In large quantities, particularly over raw surfaces or blistered areas

    When using this product

    • Use only as directed
    • Avoid contact with eyes
    • Do not wrap the treated skin with plastic wrap or other dressings or apply heat to the skin

    Stop use and ask a doctor if

    • Condition worsens or symptoms persist for more than 7 days or clear up and occurs again
    • Skin reactions occur, such as rash, itching, redness or irritation

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years and over

    • Clean and dry affected area
    • Apply once, not to exceed 3 to 4 times daily
    • Roll on affected area of skin
    • Children under 12 years of age: Consult a doctor
  • Other Information

    Store at 20-25°C (68-77°F)

    • Avoid storing product in direct sunlight
    • Protect product from excessive moistre
    • You may report serious side effects to (800) 555-8895
  • Inactive ingredients

    Acrylamide/Sodium Acrylate Copolymer, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Arnica Montana Flower Extract, Borago Officinalis Seed Oil, Boswellia Serrata Extract, Camellia Oleifera (Green Tea) Leaf Extract, Hemp Derived Isolate (HDI), Chamomilla Recutita (Matricaria) Flower Extract, Curcuma Longa (Turmeric) Root Extract, Glycerin, Harpagophytum Procumbens (Devil's Claw) Root Extract, Mentha Piperita (Peppermint) Oil, Mineral Oil, Oenothera Biennis (Evening Primrose) Oil, Polysorbate 20, Propylene Glycol, Ribes Nigrum (Black Currant) Fruit Extract, Salix Alba (White Willow) Bark Extract, SD Alcohol 40-B, Sodium Hydroxide, Trideceth-6, Water (Aqua)

  • Steel Releaf® Hemp-Derived Muscle and Joint Formula Pain Relieveing Liquid with Lidocaine and Menthol

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    PERFORMANCE BRANDS STEEL RELEAF  PAIN RELIEVING LIQUID
    lidocaine hydrochloride, menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0268
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL9.5 mg  in 1 mL
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE38 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    WATER (UNII: 059QF0KO0R)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    BLACK CURRANT (UNII: 9755T40D11)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    TURMERIC (UNII: 856YO1Z64F)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    Product Characteristics
    Colorwhite (White to off-White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0268-389 mL in 1 BOTTLE; Type 0: Not a Combination Product07/02/201910/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/02/201910/31/2024
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0268) , pack(58443-0268) , manufacture(58443-0268) , analysis(58443-0268)
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