NDC Code(s) : 0573-0711-12, 0573-0711-51
Packager : Haleon US Holdings LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ChapStick Classic Spearmintwhite petrolatum STICK
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0711
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM(UNII: 4T6H12BN9U)
(PETROLATUM - UNII:4T6H12BN9U) 		PETROLATUM450 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ARACHIDYL PROPIONATE(UNII: QV5DAH3MSB)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CETYL ALCOHOL(UNII: 936JST6JCN)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
LANOLIN(UNII: 7EV65EAW6H)
LIGHT MINERAL OIL(UNII: N6K5787QVP)
MALTOL(UNII: 3A9RD92BS4)
OCTYLDODECANOL(UNII: 461N1O614Y)
PARAFFIN(UNII: I9O0E3H2ZE)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
SACCHARIN(UNII: FST467XS7D)
WHITE WAX(UNII: 7G1J5DA97F)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
Product Characteristics
Color GREEN Score
Shape BULLET Size 42 mm
Flavor SPEARMINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0573-0711-121 in 1 BLISTER PACK 28/06/2018
14 g in 1 CYLINDER Type 0: Not a Combination Product
2NDC:0573-0711-514 g in 1 CYLINDER Type 0: Not a Combination Product28/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 06/11/2018

LABELER - Haleon US Holdings LLC(079944263)

PRINCIPAL DISPLAY PANEL

BRAND LIP CARE
ChapStick ®
SKIN PROTECTANT

CLASSIC
SPEARMINT

PROTECTS AND MOISTURIZES TO
HELP HEAL DRY, CHAPPED LIPS

NET WT 0.15 OZ (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack