NDC Code(s) : 59316-205-10, 59316-205-14, 59316-205-81, 59316-205-09, 59316-205-82
Packager : RB Health (US) LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Biofreeze Roll-OnMENTHOL GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-205
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
(MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) 		MENTHOL, UNSPECIFIED FORM40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ARNICA MONTANA FLOWER(UNII: OZ0E5Y15PZ)
FRANKINCENSE(UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
GLYCERIN(UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF(UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF(UNII: 50D2ZE9219)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TROLAMINE(UNII: 9O3K93S3TK)
WATER(UNII: 059QF0KO0R)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59316-205-1089 mL in 1 BOTTLE Type 0: Not a Combination Product17/01/2013
2NDC:59316-205-1474 mL in 1 BOTTLE Type 0: Not a Combination Product17/01/2013
3NDC:59316-205-812 in 1 CARTON 22/02/2022
3NDC:59316-205-1089 mL in 1 BOTTLE Type 0: Not a Combination Product17/01/2013
4NDC:59316-205-0937 mL in 1 BOTTLE Type 0: Not a Combination Product15/03/2024
5NDC:59316-205-822 in 1 CARTON 25/03/2024
5NDC:59316-205-1089 mL in 1 BOTTLE Type 0: Not a Combination Product15/03/2024
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 01/17/2013

LABELER - RB Health (US) LLC(081049410)

PRINCIPAL DISPLAY PANEL

CLINICALLY
RECOMMENDED*

NDC 59316-205-10

BiOFREEZE ®
COOL THE PAIN

ROLL-ON
MENTHOL-PAIN
RELIEVING GEL

3 FL OZ (89 mL)

SHAKE WELL
BEFORE EACH USE

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton