Label: LEADER ROLL-ON COOLING PAIN RELIEF TOPICAL ANALGESIC- menthol, unspecified form gel

  • NDC Code(s): 70000-0617-1
  • Packager: Cardinal Health, 110 dba LEADER
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 29, 2024

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  • SPL UNCLASSIFIED SECTION

    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, arthritis, strains, and sprains

  • Warnings

    For external use only

    Ask a doctor before use if you have sensitive skin

    When using this product

    ⬥
    Avoid contact with eyes
    ⬥
    Do not apply to wounds or damaged skin
    ⬥
    Do not use with other ointments, creams, sprays or liniments
    ⬥
    Do not apply to irritated skin or if excessive irritation develops
    ⬥
    Do not bandage tightly
    ⬥
    Wash hands after use with cool water
    ⬥
    Do not use with heating pads or heating devices

    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 excessive heat or open 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

    DIST. BY CAH DUBLIN, OH 43017

  • PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label

    LEADER™

    NDC 70000-0617-1

    Roll-On
    Cooling
    Pain Relief
    Gel

    Menthol, 4% | Topical Analgesic

    Pain Relieving Gel

    For Arthritis
    Back Pain
    Sore Muscles
    & Joints

    Hands-Free
    Roll-On
    Applicator

    Paraben-Free

    COMPARE TO
    BIOFREEZE®
    active ingredient*

    100% Money
    Back Guarantee

    2.5 FL OZ (74 mL)

    PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LEADER ROLL-ON COOLING PAIN RELIEF   TOPICAL ANALGESIC
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0617
    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:70000-0617-174 mL in 1 BOTTLE, WITH APPLICATOR; 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(70000-0617)
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