NDC Code(s) : 54723-998-01
Packager : Sambria Pharmaceuticals

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Comfortox LidocaineLIDOCAINE HYDROCHLORIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54723-998
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE(UNII: V13007Z41A)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE40 mg in 1000 mg
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER(UNII: OZ0E5Y15PZ)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)(UNII: H5BJH23Z9A)
EMU OIL(UNII: 344821WD61)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GLUCOSAMINE SULFATE(UNII: 1FW7WLR731)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
LAURETH-7(UNII: Z95S6G8201)
MELALEUCA ALTERNIFOLIA LEAF(UNII: G43C57162K)
DIMETHYL SULFONE(UNII: 9H4PO4Z4FT)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYACRYLAMIDE (10000 MW)(UNII: E2KR9C9V2I)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
STEARIC ACID(UNII: 4ELV7Z65AP)
TROLAMINE(UNII: 9O3K93S3TK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54723-998-012000 mg in 1 PACKET Type 0: Not a Combination Product14/09/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 09/14/2016

LABELER - Sambria Pharmaceuticals(078676259)

Establishment
Name Address ID/FEI Business Operations
A.I.G. Technologies, Inc. 086365223 manufacture(54723-998)

PRINCIPAL DISPLAY PANEL

Packet