Label: 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 December 3, 2019

If you are a consumer or patient please visit this version.

  • 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

    Temporary Minor Arthritis, Joint and Muscle Pain Relief

    Odor Free Therapy

    Compare to Aspercreme® active ingredient

    Trolamine Salicylate 10%

    Pain Relieving Cream

    with Aloe

    NET WT 3 OZ (85 g)

    Trolamine Salicylate Image 1
    Trolamine Salicylate Image 2
  • INGREDIENTS AND APPEARANCE
    TROLAMINE SALICYLATE 
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-356
    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:45802-356-531 in 1 CARTON11/26/2010
    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 finalpart34811/26/2010
    Labeler - Perrigo New York Inc (078846912)