NDC Code(s) : 52137-1001-2
Packager : Health Specialty.com

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

THERAPY PAINMENTHOL METHYL SALICYLATE CAPSAICIN GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52137-1001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL10 g in 100 g
METHYL SALICYLATE(UNII: LAV5U5022Y)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		METHYL SALICYLATE28 g in 100 g
CAPSAICIN(UNII: S07O44R1ZM)
(CAPSAICIN - UNII:S07O44R1ZM) 		CAPSAICIN.025 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 71DD5V995L)
PETASITES HYBRIDUS LEAF(UNII: JOS311ZC1G)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYSORBATE 60(UNII: CAL22UVI4M)
GLUCOSAMINE HYDROCHLORIDE(UNII: 750W5330FY)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
HYPROMELLOSES(UNII: 3NXW29V3WO)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
MARITIME PINE(UNII: 50JZ5Z98QY)
ZANTHOXYLUM AMERICANUM BARK(UNII: A4KL1HMZ7T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ZANTHOXYLUM BUNGEANUM WHOLE(UNII: WH9894JM8K)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
WATER(UNII: 059QF0KO0R)
WILLOW BARK(UNII: S883J9JDYX)
GAULTHERIA PROCUMBENS LEAF(UNII: 2125M16OWN)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52137-1001-2120 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/29/2012

PRINCIPAL DISPLAY PANEL

Therapy Gels Drug Fact Box

Therapy Gels Drug Fact Box