Label: LEADER ULTRA STRENGTH MUSCLE RUB TOPICAL ANALGESIC (camphor- synthetic, menthol, unspecified form, and methyl salicylate cream

  • NDC Code(s): 70000-0208-1, 70000-0208-2
  • Packager: Cardinal Health, 110 dba LEADER
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 9, 2024

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Camphor 4%Topical Analgesic
    Menthol 10.0%Topical Analgesic
    Methyl Salicylate 30%Topical Analgesic
  • Uses

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

    ♦
    arthritis
    ♦
    simple backache
    ♦
    strains
    ♦
    sprains
  • Warnings

    For external use only

    Do not use

    ♦
    with a heating pad
    ♦
    on wounds, damaged, broken or irritated skin
    ♦
    on a child under 12 years of age with arthritis-like conditions

    Ask a doctor before use if you have redness over the affected area

    When using this product

    ♦
    use only as directed
    ♦
    do not swallow
    ♦
    do not bandage tightly
    ♦
    avoid contact with the eyes and mucous membranes

    Stop use and consult a doctor if

    ♦
    skin redness or irritation develops
    ♦
    condition worsens or pain lasts for more than 7 days
    ♦
    symptoms 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 12 years of age and older: apply to affected area not more than 3 or 4 times daily
    ♦
    children under 12 years of age: ask a doctor
  • Other information

    Store at room temperature 15° - 30° C (59° - 86° F)

  • Inactive ingredients

    Carbomer, Disodium EDTA, Glyceryl Stearate SE, Lanolin, Polysorbate 80, Potassium Hydroxide, Stearic Acid, Trolamine, Water.

  • Questions or comments?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    CARDINAL HEALTH
    DUBLIN, OHIO 43017

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    NDC 70000-0208-1

    ULTRA STRENGTH
    Muscle Rub

    Topical Analgesic Pain Relief Cream

    Deep Penetrating Relief of Muscle and Arthritis Pain
    Non-Greasy Cream

    COMPARE TO
    BENGAY®
    ULTRA STRENGTH
    active ingredients*

    100% Money Back Guarantee

    NET WT 4 OZ (113 g)

    Principal Display Panel - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    LEADER ULTRA STRENGTH MUSCLE RUB   TOPICAL ANALGESIC
    camphor (synthetic), menthol, unspecified form, and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0208
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic)40 mg  in 1 g
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form100 mg  in 1 g
    Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl Salicylate300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glyceryl Stearate SE (UNII: FCZ5MH785I)  
    Lanolin (UNII: 7EV65EAW6H)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Trolamine (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0208-11 in 1 CARTON05/24/2017
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70000-0208-21 in 1 CARTON05/24/2017
    256.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01705/24/2017
    Labeler - Cardinal Health, 110 dba LEADER (063997360)
    Registrant - Garcoa, Inc (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc036464697MANUFACTURE(70000-0208)
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