NDC Code(s) : 63187-136-02, 63187-136-04
Packager : Proficient Rx LP

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dendracin NeurodendraxcinMethyl Salicylate, Menthol and Capsaicin LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-136(NDC:27495-014)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYL SALICYLATE(UNII: LAV5U5022Y)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		METHYL SALICYLATE18 g in 60 mL
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL, UNSPECIFIED FORM6 g in 60 mL
CAPSAICIN(UNII: S07O44R1ZM)
(CAPSAICIN - UNII:S07O44R1ZM) 		CAPSAICIN0.015 g in 60 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BENZOCAINE(UNII: U3RSY48JW5)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
STEARIC ACID(UNII: 4ELV7Z65AP)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHYL SULFOXIDE(UNII: YOW8V9698H)
POLOXAMER 407(UNII: TUF2IVW3M2)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
BORAGE SEED OIL(UNII: F8XAG1755S)
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
GINGER(UNII: C5529G5JPQ)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
DMDM HYDANTOIN(UNII: BYR0546TOW)
SODIUM STEAROYL GLUTAMATE(UNII: 65A9F4P024)
TROLAMINE(UNII: 9O3K93S3TK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63187-136-0250 in 1 CARTON 08/01/2014
160 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:63187-136-0450 in 1 CARTON 08/01/2014
2120 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 07/22/2011

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 RELABEL(63187-136), REPACK(63187-136)

PRINCIPAL DISPLAY PANEL

63187-136-02