NDC Code(s) : 0573-1912-12, 0573-1912-24, 0573-1912-50
Packager : Haleon US Holdings LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ChapStick Classic SpearmintPETROLATUM STICK
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-1912
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)
LEVOMENTHOL(UNII: BZ1R15MTK7)
METHYLPARABEN(UNII: A2I8C7HI9T)
OCTYLDODECANOL(UNII: 461N1O614Y)
PARAFFIN(UNII: I9O0E3H2ZE)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SACCHARIN(UNII: FST467XS7D)
SPEARMINT OIL(UNII: C3M81465G5)
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:0573-1912-121 in 1 BLISTER PACK 08/01/2012
14 g in 1 CYLINDER Type 0: Not a Combination Product
2NDC:0573-1912-241 in 1 BLISTER PACK 08/01/2012
24 g in 1 CYLINDER Type 0: Not a Combination Product
3NDC:0573-1912-504 g in 1 CYLINDER Type 0: Not a Combination Product08/01/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 08/01/2012

LABELER - Haleon US Holdings LLC(079944263)

Establishment
Name Address ID/FEI Business Operations
Fareva Richmond, Inc. 969523245 ANALYSIS(0573-1912), LABEL(0573-1912), MANUFACTURE(0573-1912), PACK(0573-1912)

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