Label: CRAMP911- magnesium sulfate, copper sulfate lotion
- NDC Code(s): 35484-924-21
- Packager: DelCorean, LLC
- 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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INGREDIENTS AND APPEARANCE
CRAMP911
magnesium sulfate, copper sulfate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35484-924 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED 0.05 [hp_X] in 1 mL BASIC COPPER SULFATE (UNII: CUP529P5NS) (COPPER - UNII:789U1901C5) BASIC COPPER SULFATE 0.05 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength 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 Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35484-924-21 1 in 1 CARTON 09/01/2008 1 21 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2008 Labeler - DelCorean, LLC (831347104) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc 793406000 manufacture(35484-924)