Label: EXTRA STRENGTH AND MUSCLE RELIEF 900 MG- menthol and lidocaine gel

  • 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 March 18, 2019

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  • Uses

    Temporary relief of minor arthritis, backache, muscle and joint pain

  • Warnings

    For external use only
    Allergy alert: If prone to allergic reaction to latex, consult a doctor before use. Symptoms may include: • rash • blisters • skin reddening
    If a skin reaction occurs, stop use and seek medical help right away.

  • Directions

    • adults and children 12 and older: Apply 1 to 4 pumps to areas of pain and discomfort. Reapply as necessary using no more than 4 times daily.
    • children under the age of 12: Do not use, ask a doctor

  • When using this product:

    • Use only as directed • Avoid contact with eyes and mucous membranes • do not use with a heating pad • do not bandage tightly

    • do not apply to wounds or damaged skin

  • Stop and ask doctor if

    • condition worsens • symptoms last for more than 7 days • symptoms clear up and occur again within a few days • redness or irritation occurs

  • storage

    • Store at 20-35 deg C (68-77deg F).

  • Keep out of reach of children and pets

    If swallowed, get medical help or contact poison control right away.

  • Active Ingredients & Purpose

    Menthol 4%----------------- Analgesic

    Lidocaine 3%--------------- Analgesic

  • Inactive Ingredient

    bergamot oil, carbomer 940, caderwood oil, devil' claw extract, ethanol, geranium oil, Glydant Plus, hemp extract cannabidiol oil, horse chestnut seed extract, lavender oil, oleic acid, propylene glycol, purified water, soya photidylcholine, triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    JOINT AND MUSCLE RELIEF GEL

  • PRINCIPAL DISPLAY PANEL

    JOINT AND MUSCLE RELIEF GEL

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH AND MUSCLE RELIEF 900 MG 
    menthol and lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72800-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    CARBOMER 934 (UNII: Z135WT9208)  
    JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    ALCOHOL (UNII: 3K9958V90M)  
    GERANIUM THUNBERGII FLOWERING TOP (UNII: 9IXM1668B6)  
    HEMP (UNII: TD1MUT01Q7)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    1,2-DILINOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 7L874P1M1O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72800-002-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product03/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/05/2019
    Labeler - Lifecure Rx Specialty Pharmacy (116913965)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifecure Rx Specialty Pharmacy116913965manufacture(72800-002)
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