CRAMP911- magnesium sulfate, copper sulfate lotion 
DelCorean, LLC

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.

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dosage and administration section

warnings section

inactive ingredient section

otc- keep out of reach of children

OTC- active ingredient section

OTC- purpose section

indications and usage section

package label principle display panel

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
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED0.05 [hp_X]  in 1 mL
BASIC COPPER SULFATE (UNII: CUP529P5NS) (COPPER - UNII:789U1901C5) BASIC COPPER SULFATE0.05 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DOCUSATE SODIUM/SODIUM BENZOATE (UNII: 656HXR6YXN)  
SORBIC ACID (UNII: X045WJ989B)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
UREA (UNII: 8W8T17847W)  
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GUAIFENESIN (UNII: 495W7451VQ)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35484-924-211 in 1 CARTON09/01/2008
121 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)

Revised: 12/2023
Document Id: 0d1b2f8d-a750-ea40-e063-6394a90a334f
Set id: 481f5af0-deb4-5bd3-e054-00144ff8d46c
Version: 7
Effective Time: 20231222
 
DelCorean, LLC