Label: EPSAL- magnesium sulfate, unspecified form ointment

  • NDC Code(s): 11649-0001-3
  • Packager: Press Chemical and Pharmaceutical Laboratories
  • Category: HUMAN OTC DRUG LABEL

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 January 24, 2020

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  • INDICATIONS & USAGE

    Epsal Ointment, a Specially Suspended Epsom Salts Drawing Ointment is Recommended for External Application to draw foreign substances from below the surface of the skin, as for example, a sliver of wood or a stinger from a bee bite.

  • DIRECTIONS

    Apply a heaping quantity to affected parts one or two times a day. Bandage loosely to protect the clothing if necessary.

  • Active Ingredient

    Magnesium Sulfate 40%.

  • Inactive Ingredients

    Purified Water, White Petrolatum, Mineral Oil, Microcrystalline Wax, Lanolin Alcohol

  • WARNINGS

    FOR EXTERNAL USE ONLY. CAUTION: In case of deep or puncture wounds or serious burns, consult physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult physician.

  • WARNING

    KEEP OUT OF REACH OF CHILDREN

  • SPL UNCLASSIFIED SECTION

    NDC #11649-0001-3

    Distributed By
    PRESS CHEMICAL & PHARMACEUTICAL LAB
    COLUMBUS, OHIO 43209

  • PRINCIPAL DISPLAY PANEL - 60 gram Jar Label

    Epsal®
    OINTMENT

    NET WT. 2 OZ. (60 grams)

    Principal Display Panel - 60 gram Jar Label
  • INGREDIENTS AND APPEARANCE
    EPSAL 
    magnesium sulfate, unspecified form ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11649-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) Magnesium Sulfate, Unspecified Form400 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Petrolatum (UNII: 4T6H12BN9U) 143 mg  in 1 g
    Mineral Oil (UNII: T5L8T28FGP)  
    Microcrystalline Wax (UNII: XOF597Q3KY)  
    Lanolin Alcohols (UNII: 884C3FA9HE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11649-0001-312 in 1 BOX01/15/1957
    160 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/15/1957
    Labeler - Press Chemical and Pharmaceutical Laboratories (059935494)
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