NDC Code(s) : 71148-103-05
Packager : Kowa Health Care America, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

VANTELIN HOT PAIN RELIEVING capsaicin, methyl salicylate PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71148-103
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN(UNII: S07O44R1ZM)
(CAPSAICIN - UNII:S07O44R1ZM) 		CAPSAICIN0.04 1 in 100 1
METHYL SALICYLATE(UNII: LAV5U5022Y)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		METHYL SALICYLATE10 1 in 100 1
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
CASTOR OIL(UNII: D5340Y2I9G)
DIHYDROXYALUMINUM AMINOACETATE(UNII: DO250MG0W6)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
2-ETHYLHEXYL ACRYLATE(UNII: HR49R9S6XG)
METHYL ACRYLATE(UNII: WC487PR91H)
NONOXYNOL-30(UNII: JJX07DG188)
SODIUM POLYACRYLATE (2500000 MW)(UNII: 05I15JNI2J)
POLYACRYLIC ACID (250000 MW)(UNII: 9G2MAD7J6W)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
WATER(UNII: 059QF0KO0R)
SORBITOL(UNII: 506T60A25R)
TARTARIC ACID(UNII: W4888I119H)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Product Characteristics
Color white Score
Shape RECTANGLE Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71148-103-051 in 1 BOX 03/09/2017
15 in 1 POUCH 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 03/09/2017 12/31/2018

PRINCIPAL DISPLAY PANEL

Kowa

VANTELIN 

HOT PAIN RELIEVING GEL PATCH

Capsaicin 0.04%

Methyl salicylate 10%

NECK & SHOULDER 

LOWER BACK

Deep Penetrating, Medical Strength Relief 

Lasts up to 8 Hours*

*when used as directed 

5 Patches

3-1/8" x 4 -3/4" (8cm x 12 cm) each 

Hot Patch Carton