Otc - Active Ingredient
Active ingredient ...............................Purpose
Trolamine salicylate 10%.....................Topical analgesic
Mobisyl Cream
FDA Label NDC 0225-0360
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bf Ascher And Co Inc for the product Mobisyl (NDC 0225-0360). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - 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
Otc - Do Not Use
Do not use
- on or near the eyes
- on broken, damaged, or irritated skin
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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
Otc - Questions
Questions? Call 1-800-324-1880, 7:30am - 4:00pm Central, M - F, or visit www.bfascher.com
Package Label.Principal Display Panel
Mobisyl 8oz PDP
Mobisyl 8oz Pdp (Mobisyl8)
Mobisyl 3.5oz PDP
Mobisyl 3.5oz Pdp (Mobisyl35)
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