NDC Code(s) : 69336-500-02
Packager : Sterling Knight Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AdazinCapsaicin/Benzocaine/Lidocaine/Methyl Salicylate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69336-500
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN(UNII: S07O44R1ZM)
(CAPSAICIN - UNII:S07O44R1ZM) 		CAPSAICIN0.035 g in 100 g
BENZOCAINE(UNII: U3RSY48JW5)
(BENZOCAINE - UNII:U3RSY48JW5) 		BENZOCAINE2 g in 100 g
LIDOCAINE(UNII: 98PI200987)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE2 g in 100 g
METHYL SALICYLATE(UNII: LAV5U5022Y)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		METHYL SALICYLATE1.0 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
TROLAMINE SALICYLATE(UNII: H8O4040BHD)
GLYCERIN(UNII: PDC6A3C0OX)
DIMETHYL ISOSORBIDE(UNII: SA6A6V432S)
PEG-100 STEARATE(UNII: YD01N1999R)
PEG-8 STEARATE(UNII: 2P9L47VI5E)
VANILLYL BUTYL ETHER(UNII: S2ULN37C9R)
CETYL ALCOHOL(UNII: 936JST6JCN)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
TRIDECYL STEARATE(UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE(UNII: VLW429K27K)
TRIDECYL TRIMELLITATE(UNII: FY36J270ES)
STEARIC ACID(UNII: 4ELV7Z65AP)
WHITE WAX(UNII: 7G1J5DA97F)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ALOE VERA WHOLE(UNII: KIZ4X2EHYX)
(C10-C30)ALKYL METHACRYLATE ESTER(UNII: XH2FQZ38D8)
ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER(UNII: B9J55EA6QX)
NAPROXEN(UNII: 57Y76R9ATQ)
GLUCOSAMINE(UNII: N08U5BOQ1K)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
BOSWELLIA SERRATA WHOLE(UNII: X7B7P649WQ)
ARNICA MONTANA FLOWER(UNII: OZ0E5Y15PZ)
MONOSODIUM METHYLARSONATE(UNII: 600QCW45IV)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
EAST INDIAN LEMONGRASS OIL(UNII: UP0M8M3VZW)
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69336-500-0260 g in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/03/2014

PRINCIPAL DISPLAY PANEL

adazin carton