Label: CRAMP911- magnesium sulfate, copper sulfate lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 22, 2023

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  • DOSAGE & ADMINISTRATION

    dosage and administration section

  • WARNINGS

    warnings section

  • INACTIVE INGREDIENT

    Inactive ingredient section

  • KEEP OUT OF REACH OF CHILDREN

    OTC- keep out of reach of children

  • ACTIVE INGREDIENT

    OTC-Active ingredient section

  • PURPOSE

    OTC_ Purpose section

  • INDICATIONS & USAGE

    indications and usage

  • PRINCIPAL DISPLAY PANEL

    package label principle display panel

  • INGREDIENTS AND APPEARANCE
    CRAMP911 
    magnesium sulfate, copper sulfate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35484-924
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BASIC COPPER SULFATE (UNII: CUP529P5NS) (COPPER - UNII:789U1901C5) BASIC COPPER SULFATE0.05 [hp_X]  in 1 mL
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM0.05 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    UREA (UNII: 8W8T17847W)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    DOCUSATE SODIUM/SODIUM BENZOATE (UNII: 656HXR6YXN)  
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GUAIFENESIN (UNII: 495W7451VQ)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    SORBIC ACID (UNII: X045WJ989B)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35484-924-041 in 1 CARTON09/01/2008
    14.5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2008
    Labeler - DelCorean, LLC (831347104)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc793406000manufacture(35484-924)
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