Label: BLUESTOP MAX- external analgesic gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2024

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  • Active Ingredients

    Lidocaine HCl 4%

    Menthol 1%

  • Purpose

    Topical Analgesic

  • Use

    Temporary relief of pain

  • Warnings

    For external use only

    When using this product avoid contact with eyes

    Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

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

  • Directions

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: Consult a doctor.
  • Other Information

    Store at room temperature

    Avoid excessive hrat

  • Inactive Ingredients

    Aloe Vera Leaf, Alpha-Tocopherol Acetate, Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate and Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.S), Cetyl Alcohol, Coconut Oil, Dimethyl Sulfone, Ethylhexylglycerin,Ethylhexyl Palmitate, Fragrance, Garcinia Indica Seed Butter, Glucosamine Sulfate, Glycerin, Melaleuca Alternifolia Leaf, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW), Vitamin A Palmitate, Water, Witch Hazel

  • Questions or Comments

    1-800-432-5464

  • Roll-On and Carton Labels

    Roll-On Carton LabelRoll-On Label

  • INGREDIENTS AND APPEARANCE
    BLUESTOP MAX 
    external analgesic gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82714-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WITCH HAZEL (UNII: 101I4J0U34)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82714-001-011 in 1 CARTON01/10/2023
    185 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/10/2023
    Labeler - Clavel Corporation (927855643)
    Establishment
    NameAddressID/FEIBusiness Operations
    TAKA USA Inc, dba Cosmetic Innovations802860515manufacture(82714-001)
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