NDC Code(s) : 0536-1121-97
Packager : RUGBY LABORATORIES

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rugby Cooling PainMENTHOL GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0536-1121
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT(UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER(UNII: OZ0E5Y15PZ)
FRANKINCENSE(UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
GLYCERIN(UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF(UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF(UNII: 50D2ZE9219)
TROLAMINE(UNII: 9O3K93S3TK)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0536-1121-97118 mL in 1 TUBE Type 0: Not a Combination Product06/10/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/10/2017

PRINCIPAL DISPLAY PANEL

Label