Label: MD80 CLINICAL STRENGTH TOPICAL ANALGESIC- menthol 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 May 2, 2022

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  • Drug Facts

  • Active ingredient

    Menthol 4%

  • Purpose

    Topical analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • simple backache
    • strains
    • sprains
    • bruises
    • arthritis
  • Warnings

    For external use only.

    Do not use

    • on large areas of the body
    • with other ointments, creams, sprays or liniments
    • with heating pad

    Ask a doctor before use if you have

    sensitive skin or redness over the affected area

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not apply to wounds or damaged skin
    • do not bandage
    • wash hands after use

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children.

    If accidentally ingested, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Use only as directed
    • Adults and children over 12 years: apply to affected area not more than 4 times daily.
    • Children under 12 years of age: Consult physician.
  • Other information

    Store in cool dry place

  • Inactive ingredients

    Alcohol Denat., Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Butylene Glycol, Diethyl Nonanedioate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isopropyl Alcohol, Methyl Hydroxypropyl Cellulose, Polyacrylate Crosspolymer 6, Polysorbate 20, Water

  • Questions?

    1-806-319-8845 or md80relief.com

  • Company Information

    Distributed by Skin Sherpa North America, LLC, 18756 Stone Oak Pkwy, Ste. 200 San Antonio, TX 78258

    www.md80relief.com

  • Product Packaging

    md80

  • INGREDIENTS AND APPEARANCE
    MD80 CLINICAL STRENGTH TOPICAL ANALGESIC 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80967-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    DIETHYL AZELATE (UNII: 4E9QQ39A4X)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80967-004-011 in 1 BOX05/02/2022
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:80967-004-033 in 1 BOX05/02/2022
    23 mL in 1 PACKET; Type 0: Not a Combination Product
    3NDC:80967-004-1010 in 1 BOX05/02/2022
    33 mL in 1 PACKET; Type 0: Not a Combination Product
    4NDC:80967-004-2020 in 1 BOX05/02/2022
    43 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/02/2022
    Labeler - SKIN SHERPA NORTH AMERICA LLC (117719003)
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