Label: LEADER MAXIMUM STRENGTH PAIN RELIEVING ANALGESIC- trolamine salicylate cream

  • NDC Code(s): 70000-0169-1
  • 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 ingredients

    Trolamine Salicylate

  • Purpose

    Topical Analgesic

  • Uses

    temporarily relieves minor pain associated with:

    ♦
    arthritis
    ♦
    simple backache
    ♦
    muscle strains
    ♦
    sprains
    ♦
    bruises
    ♦
    cramps
  • Warnings

    For external use only

    Allergy alert!

    If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    When using this product

    ♦
    use only as directed. Read an follow all directions and warnings on this label
    ♦
    do not bandage tightly or apply local heat (such as heating pads) to the area of use
    ♦
    avoid contact with eyes and mucous membranes
    ♦
    do not apply to wounds or damaged, broken or irritated skin
    ♦
    do not use at the same time as other topical analgesics

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

    ♦
    redness is present
    ♦
    irritation develops

    If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

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

  • Directions

    ♦
    Adults and children 12 years of age and older: apply to affected area not more than 4 times per day. Massage into painful area until thoroughly absorbed into skin
    ♦
    children under 12 years of age: do not use, consult a doctor
  • Other information

    Store at room temperature

  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Cetyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Sodium Hydroxide, Stearic Acid, Water.

  • Questions or comments?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    CARDINAL HEALTH
    DUBLIN, OHIO 43017

  • PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

    MAXIMUM STRENGTH

    NDC 70000-0169-1

    Pain Relieving Cream
    Trolamine Salicylate, 10%

    Topical Analgesic Rub

    Temporary Relief of Minor Muscle Aches and Pains
    Associated with Arthritis, Simple Backache or Sprains

    Fast Acting • Odor Free • With Aloe

    COMPARE TO
    ASPERCREME®
    MAXIMUM STRENGTH
    active ingredients*

    100% Money Back Guarantee

    NET WT 3 OZ (85 g)

    PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    LEADER MAXIMUM STRENGTH PAIN RELIEVING   ANALGESIC
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0169
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Trolamine Salicylate (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) Trolamine Salicylate100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Potassium Phosphate, Unspecified Form (UNII: B7862WZ632)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0169-11 in 1 CARTON08/31/2017
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01708/31/2017
    Labeler - Cardinal Health, 110 dba LEADER (063997360)
    Registrant - Garcoa, Inc (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc036464697MANUFACTURE(70000-0169)
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