LEADER COOLING PAIN RELIEF TOPICAL ANALGESIC- menthol, unspecified form gel

Leader Cooling Pain Relief by

Drug Labeling and Warnings

Leader Cooling Pain Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba LEADER, Garcoa, Inc., Sigan Industries INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Flammable

  • ⬥ keep away from fire or flame
  • If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately.

  • 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 in a cool dry place with lid closed tightly.

  • Inactive ingredients

    aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5.

  • Questions or comments?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017

  • PRINCIPAL DISPLAY PANEL - 89 mL Tube Label

    LEADER

    NDC: 70000-0618-1

    Cooling
    Pain Relief
    Gel

    Menthol, 4% | Topical Analgesic

    Pain Relieving Gel

    For Backache
    Muscle Pain
    Joint Pain

    Soothing
    Menthol

    COMPARE TO
    BIOFREEZE®
    active ingredient*

    100% Money
    Back Guarantee

    3 FL OZ (89 mL)

    PRINCIPAL DISPLAY PANEL - 89 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    LEADER COOLING PAIN RELIEF   TOPICAL ANALGESIC
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70000-0618
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Arnica Montana Flower (UNII: OZ0E5Y15PZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Water (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70000-0618-189 mL in 1 TUBE; Type 0: Not a Combination Product11/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01711/03/2022
    Labeler - Cardinal Health, 110 dba LEADER (063997360)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(70000-0618)

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