NDC Code(s) : 35813-375-34, 35813-375-94
Packager : ANASTASIA MARIE LABORATORIES, INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DIAPEDIC FOOT AND LEG TREATMENTMENTHOL CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35813-375
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL1.8 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
SAFFLOWER OIL(UNII: 65UEH262IS)
PARAFFIN(UNII: I9O0E3H2ZE)
OCTYL STEARATE(UNII: 772Y4UFC8B)
OLIVE OIL(UNII: 6UYK2W1W1E)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
LANOLIN(UNII: 7EV65EAW6H)
METHYL SALICYLATE(UNII: LAV5U5022Y)
YELLOW WAX(UNII: 2ZA36H0S2V)
TROLAMINE(UNII: 9O3K93S3TK)
.ALPHA.-TOCOTRIENOL(UNII: B6LXL1832Y)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETETH-20(UNII: I835H2IHHX)
LINOLEIC ACID(UNII: 9KJL21T0QJ)
LINOLENIC ACID(UNII: 0RBV727H71)
ARACHIDONIC ACID(UNII: 27YG812J1I)
EUCALYPTUS OIL(UNII: 2R04ONI662)
BERGAMOT OIL(UNII: 39W1PKE3JI)
EVENING PRIMROSE OIL(UNII: 3Q9L08K71N)
ALLANTOIN(UNII: 344S277G0Z)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
TOCOPHEROL(UNII: R0ZB2556P8)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
PANTHENOL(UNII: WV9CM0O67Z)
CAMPHOR (SYNTHETIC)(UNII: 5TJD82A1ET)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
STEARETH-2(UNII: V56DFE46J5)
STEARETH-21(UNII: 53J3F32P58)
STEARIC ACID(UNII: 4ELV7Z65AP)
CARBOMER 934(UNII: Z135WT9208)
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW)(UNII: 997385V0VV)
CETYL ALCOHOL(UNII: 936JST6JCN)
XANTHAN GUM(UNII: TTV12P4NEE)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35813-375-941 in 1 BOX
1NDC:35813-375-34113.4 g in 1 JAR 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 08/31/2011

PRINCIPAL DISPLAY PANEL

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