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
- INDICATIONS & USAGE
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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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
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INGREDIENTS AND APPEARANCE
MOBISYL
trolamine salicylate creamProduct 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 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 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)