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
  • 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 June 25, 2021

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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 NOT FINALpart34805/24/2017
    Labeler - Cardinal Health, 110 dba LEADER (063997360)
    Registrant - Garcoa, Inc (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc036464697MANUFACTURE(70000-0208)
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