CRAMP911- magnesium sulfate, copper sulfate lotion

Cramp911 by

Drug Labeling and Warnings

Cramp911 by is a Homeopathic medication manufactured, distributed, or labeled by DelCorean, LLC, Fragrance Manufacturing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

WARNINGS

INACTIVE INGREDIENT

KEEP OUT OF REACH OF CHILDREN

ACTIVE INGREDIENT

PURPOSE

INDICATIONS & USAGE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CRAMP911 
magnesium sulfate, copper sulfate lotion

Product 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
WATER (UNII: 059QF0KO0R)
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)

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)