Label: SUNMARK ARTHRICREAM RUB- trolamine salicylate cream

  • NDC Code(s): 49348-883-84
  • Packager: Strategic Sourcing Services LLC
  • 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 May 5, 2020

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  • Active ingredient

    Trolamine salicylate 10%

  • Purpose

    Topical analgesic

  • Uses

    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 this product

    •
    use only as directed
    •
    do not bandage tightly or use with a heating pad
    •
    avoid contact with the eyes or mucous membranes
    •
    do not apply to wounds or damaged skin

    Stop use and ask 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

    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 Center right away. (1-800-222-1222)

  • 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 or younger: ask a doctor

  • Other information

    •
    store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    aloe barbadensis leaf juice, cetyl alcohol, edetate disodium, glycerin, methylparaben, mineral oil, potassium phosphate, propylparaben, stearic acid, triethanolamine, water

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    COMPARE TO ASPERCREME® PAIN RELIEVING CREME ACTIVE INGREDIENT

    Trolamine salicylate, 10%

    PAIN RELIEVING CREAM

    arthricream rub

    WITH ALOE

    Trolamine salicylate, 10%

    PAIN RELIEVING CREAM

    NET WT 3 OZ (85 g)

    251-s1-arthricream-rub-1.jpg
    251-s1-arthricream-rub-2.jpg
  • INGREDIENTS AND APPEARANCE
    SUNMARK ARTHRICREAM RUB 
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-883
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-883-841 in 1 CARTON06/10/2009
    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 finalpart34806/10/2009
    Labeler - Strategic Sourcing Services LLC (116956644)
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