Label: MOBISYL- trolamine salicylate cream

  • NDC Code(s): 0225-0360-11, 0225-0360-35
  • Packager: BF ASCHER AND CO INC
  • 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 November 2, 2022

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  • ACTIVE INGREDIENT

    Active ingredient ...............................Purpose
    Trolamine salicylate 10%.....................Topical analgesic

  • INDICATIONS & USAGE

    Use

    For temporarily relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, lumbago, neuralgia, strains, bruises, and sprains

  • PURPOSE

    Use

    Temporarily relieves minor aches and pains of muscles and joints associated with arthritis, simple backache, lumbago, neuralgia, strains, bruises, and sprains.

  • WARNINGS

    Warnings
    For external use only.
    Use only as directed

  • DO NOT USE

    Do not use

    • on or near the eyes
    • on broken, damaged, or irritated skin
  • ASK DOCTOR

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

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children. In case of ingestion, get medical help or contact a poison control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years and older: massage a liberal amount into the affected area three or four times a day, especially before retiring
    • children under 12 years of age: consult your doctor
  • STORAGE AND HANDLING

    Other information

    • store tightly capped at 59°- 86° F (15°- 30° C)
    • mfd. in the USA for B.F. Ascher & Co., Inc.
  • INACTIVE INGREDIENT

    Inactive ingredients: allantoin, aloe vera gel, carbomer, cetyl alcohol, citric acid, diazolidinyl urea, glycerin, glyceryl stearate, iodopropynyl butylcarbamate, isopropyl palmitate, lecithin, mineral oil, potassium sorbate, propylene glycol, sodium benzoate, sodium dehydroacetate, sodium hydroxide, sodium sulfite, stearic acid, sweet almond oil, tetrasodium EDTA, and water

  • QUESTIONS

    Questions? Call 1-800-324-1880, 7:30am - 4:00pm Central, M - F, or visit www.bfascher.com

  • PRINCIPAL DISPLAY PANEL

    Mobisyl 8oz PDPMobisyl 8oz PDP

    Mobisyl 3.5oz PDP

    Mobisyl 3.5oz PDP

  • INGREDIENTS AND APPEARANCE
    MOBISYL 
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0225-0360
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALOE (UNII: V5VD430YW9)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0225-0360-35226.8 g in 1 JAR; Type 0: Not a Combination Product09/19/2014
    2NDC:0225-0360-11100 g in 1 TUBE; Type 0: Not a Combination Product09/19/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/19/2014
    Labeler - BF ASCHER AND CO INC (003854403)
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