MOBISYL- trolamine salicylate cream

MOBISYL by

Drug Labeling and Warnings

MOBISYL by is a Otc medication manufactured, distributed, or labeled by BF ASCHER AND CO INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 PDP

Mobisyl 3.5oz PDP

INGREDIENTS AND APPEARANCE

MOBISYL 
trolamine salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0225-0360
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM SULFITE (UNII: VTK01UQK3G)
CARBOMER 940 (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0225-0360-35	226.8 g in 1 JAR; Type 0: Not a Combination Product	09/19/2014
2	NDC: 0225-0360-11	100 g in 1 TUBE; Type 0: Not a Combination Product	09/19/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/19/2014

Labeler - BF ASCHER AND CO INC (003854403)