NDC Code(s) : 10742-8189-1
Packager : The Mentholatum Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lip Relief French Vanillawhite petrolatum, octinoxate, oxybenzone STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10742-8189
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM(UNII: 4T6H12BN9U)
(PETROLATUM - UNII:4T6H12BN9U) 		PETROLATUM407 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE35 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PARAFFIN(UNII: I9O0E3H2ZE)
WHITE WAX(UNII: 7G1J5DA97F)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
MINERAL OIL(UNII: T5L8T28FGP)
ISOCETYL STEARATE(UNII: 3RJ7186O9W)
CARNAUBA WAX(UNII: R12CBM0EIZ)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
SHEA BUTTER(UNII: K49155WL9Y)
CETYL ALCOHOL(UNII: 936JST6JCN)
COCONUT OIL(UNII: Q9L0O73W7L)
LANOLIN(UNII: 7EV65EAW6H)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10742-8189-11 in 1 BLISTER PACK 01/07/2016
12 g in 1 CYLINDER 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 part352 07/01/2016 06/30/2018

PRINCIPAL DISPLAY PANEL

Lip Relief French Vanilla

PRINCIPAL DISPLAY PANEL

Drug Facts