Mobisyl

Drug Labeling and Warnings

Drug Details [pdf]

MOBISYL- trolamine salicylate cream 
Lake Erie Medical DBA Quality Care Products LLC

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.

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Mobisyl

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

Use

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

Use

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

Warnings
For external use only.
Use only as directed

Do not use

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

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.

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

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

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

Other information

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

Inactive ingredients: allantoin, aloe barbadensis leaf juice (aloe vera gel), carbomer, cetyl alcohol, diazolidinyl urea, glycerin, glyceryl stearate, isopropyl palmitate, lecithin, methylparaben, mineral oil, propylene glycol, propylparaben, sodium hydroxide, stearic acid, sweet almond oil, tetrasodium EDTA, and water

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

Image of Label

Image of Label

MOBISYL 
trolamine salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55700-193(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
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE (UNII: V5VD430YW9)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55700-193-35100 g in 1 JAR; Type 0: Not a Combination Product09/19/201410/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/19/201410/11/2019
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIBusiness Operations
Lake Erie Medical DBA Quality Care Products LLC831276758relabel(55700-193)

Revised: 10/2019
Document Id: 9a25cf0b-3e30-4de9-a57e-8234570fc1c5
Set id: 4d3e0e75-cd77-4174-9316-163f5fe05349
Version: 2
Effective Time: 20191030
 
Lake Erie Medical DBA Quality Care Products LLC