Label: EQUATE ODOR-FREE THERAPY ARTHRITIS ANALGESIC- trolamine salicylate cream

  • 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 April 1, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Trolamine Salicylate 10%

  • Purpose

    Topical Analgesic

  • Uses

    temporarily relieves minor pain associated with

    ⬥
    arthritis
    ⬥
    simple backache
    ⬥
    strains
    ⬥
    sprains
    ⬥
    bruises
  • 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 and follow all directions and warnings on this carton
    ⬥
    avoid contact with eyes and mucous membranes
    ⬥
    do not use at the same time as other topical analgesics
    ⬥
    do not apply to wounds or damaged skin
    ⬥
    do not bandage tightly
    ⬥
    do not use with heating pads or other heating devices

    Stop use and consult a doctor if

    ⬥
    condition worsens
    ⬥
    symptoms persist for more than 7 days or clear up and occur again within a few days
    ⬥
    redness is present
    ⬥
    irritation develops

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

    If pregnant or breast feeding, seek the advice of a health care professional before use.

  • Directions

    ⬥
    Adults and children 12 years of age and older: apply to affected area no more than 3 to 4 times daily
    ⬥
    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?

    1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    Walmart Inc.,
    Bentonville, AR 72716

  • PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

    NDC 79903-117-01

    equate™

    Compare to
    Aspercreme®
    Pain Relieving
    Cream active
    ingredient*

    ODOR-FREE THERAPY

    Arthritis Cream

    10% Trolamine Salicylate
    Pain Relieving Cream with Aloe

    • Temporary relief for minor arthritis,
      joint and muscle pain

    NET WT 3 OZ (85g)

    PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    EQUATE ODOR-FREE THERAPY ARTHRITIS   ANALGESIC
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-117
    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:79903-117-011 in 1 CARTON03/25/2022
    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 NOT FINALpart34804/01/2019
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(79903-117)
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