NDC Code(s) : 69743-513-23
Packager : Galxee, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

RHEMURHEMU ANALGESIC CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69743-513
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL0.07 g in 1 g
METHYL SALICYLATE(UNII: LAV5U5022Y)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		METHYL SALICYLATE0.1 g in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
EMU OIL(UNII: 344821WD61)
GLYCERIN(UNII: PDC6A3C0OX)
EUCALYPTUS GLOBULUS LEAF(UNII: S546YLW6E6)
STEARIC ACID(UNII: 4ELV7Z65AP)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
CARBOMER 1342(UNII: 809Y72KV36)
AVOCADO OIL(UNII: 6VNO72PFC1)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PHENETHYL ALCOHOL(UNII: ML9LGA7468)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ARNICA MONTANA FLOWER(UNII: OZ0E5Y15PZ)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69743-513-231 in 1 BOX
1170 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/15/2014

PRINCIPAL DISPLAY PANEL

Image of Carton Label