Label: ARTHRITIS CREAM- trolamine salicylate 10% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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  • ACTIVE INGREDIENT

    Trolamine Salicylate 10%

  • PURPOSE

    Topical analgesic

  • INDICATIONS & USAGE

    Temporarily relieves minor pain associated with:

    Arthritis

    Simple backache

    muscle 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 the product

    use only as directed

    do not bandage tightly or use with a heating pad

    avoid contact with eyes or mucous membranes

    do not apply to wounds or damaged skin

    Stop use and ask doctor if

    condition worsens

    symptoms persist for more than 7 days or clear up and occur again within few days

    redness is present

    irritation develops

    If pregnant or breast feeding, ask a health professional before use.

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

  • DOSAGE & ADMINISTRATION

    Directions:

    adults and children over 12 years:

    apply generously to affected area

    massage into painful area until thoroughly absorbed into skin

    repeat as necessary, but not more than 4 times daily

    Children 12 years and younger: ask a doctor

  • OTHER SAFETY INFORMATION

    Store at 20° - 25°C (68° - 77°F)

  • INACTIVE INGREDIENT

    Aloe barbadensis leaf juice, cetyl alcohol, glycerin, mineral oil, phenoxyethanol, stearic acid, triethanolamine, water, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    Package LabelPackage Carton

  • INGREDIENTS AND APPEARANCE
    ARTHRITIS CREAM 
    trolamine salicylate 10% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-990
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-990-1085 g in 1 TUBE; Type 0: Not a Combination Product09/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/15/2022
    Labeler - CVS (062312574)