NDC Code(s) : 71718-111-01, 71718-111-02, 71718-111-03, 71718-111-04, 71718-111-05, 71718-111-06
Packager : Scientific Solutions Global Llc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BioTemperMenthol LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71718-111
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL, UNSPECIFIED FORM10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ARNICA MONTANA WHOLE(UNII: O80TY208ZW)
FRANKINCENSE(UNII: R9XLF1R1WM)
CAMPHOR (SYNTHETIC)(UNII: 5TJD82A1ET)
FRANKINCENSE OIL(UNII: 67ZYA5T02K)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(UNII: 9XZ8H6N6OH)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
LAVENDER OIL(UNII: ZBP1YXW0H8)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TEA TREE OIL(UNII: VIF565UC2G)
THYMOL(UNII: 3J50XA376E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71718-111-0189 mL in 1 BOTTLE Type 0: Not a Combination Product08/03/2017
2NDC:71718-111-022 in 1 PACKAGE 08/03/2017
289 mL in 1 BOTTLE Type 0: Not a Combination Product08/03/2017
3NDC:71718-111-033 in 1 PACKAGE 08/03/2017
389 mL in 1 BOTTLE Type 0: Not a Combination Product08/03/2017
4NDC:71718-111-044 in 1 PACKAGE 08/03/2017
489 mL in 1 BOTTLE Type 0: Not a Combination Product08/03/2017
5NDC:71718-111-056 in 1 PACKAGE 08/03/2017
589 mL in 1 BOTTLE Type 0: Not a Combination Product08/03/2017
6NDC:71718-111-0612 in 1 PACKAGE 08/03/2017
689 mL in 1 BOTTLE Type 0: Not a Combination Product08/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 08/03/2017

LABELER - Scientific Solutions Global Llc(097291290)

Establishment
Name Address ID/FEI Business Operations
Scientific Solutions Global Llc 097291290 manufacture(71718-111)

PRINCIPAL DISPLAY PANEL

Bio-Rollon1