NDC Code(s) : 0573-0720-12, 0573-0720-51, 0573-0720-70
Packager : Haleon US Holdings LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CHAPSTICK MEDICATEDcamphor, menthol, petrolatum, phenol STICK
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0720
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC)(UNII: 5TJD82A1ET)
(CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) 		CAMPHOR (SYNTHETIC)10 mg in 1 g
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
(MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) 		MENTHOL, UNSPECIFIED FORM6 mg in 1 g
PETROLATUM(UNII: 4T6H12BN9U)
(PETROLATUM - UNII:4T6H12BN9U) 		PETROLATUM410 mg in 1 g
PHENOL(UNII: 339NCG44TV)
(PHENOL - UNII:339NCG44TV) 		PHENOL5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ARACHIDYL PROPIONATE(UNII: QV5DAH3MSB)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CETYL ALCOHOL(UNII: 936JST6JCN)
COCOA BUTTER(UNII: 512OYT1CRR)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
LANOLIN(UNII: 7EV65EAW6H)
LIGHT MINERAL OIL(UNII: N6K5787QVP)
OCTYLDODECANOL(UNII: 461N1O614Y)
OLEYL ALCOHOL(UNII: 172F2WN8DV)
PARAFFIN(UNII: I9O0E3H2ZE)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
WHITE WAX(UNII: 7G1J5DA97F)
Product Characteristics
Color yellow Score
Shape BULLET (Cylindrical) Size 42 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0573-0720-121 in 1 BLISTER PACK 06/10/2018
14 g in 1 CYLINDER Type 0: Not a Combination Product
2NDC:0573-0720-514 g in 1 CYLINDER Type 0: Not a Combination Product06/10/2018
3NDC:0573-0720-702 in 1 BLISTER PACK 06/10/2018
34 g in 1 CYLINDER Type 0: Not a Combination Product06/10/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 06/10/2018

LABELER - Haleon US Holdings LLC(079944263)

PRINCIPAL DISPLAY PANEL

BRAND LIP CARE

ChapStick ®

EXTERNAL ANALGESIC | SKIN PROTECTANT

CLASSIC
MEDICATED

SOOTHES, COOLS & PROTECTS TO
RELIEVE SEVERELY DRY, CHAPPED LIPS

NET WT 0.15 OZ (4 g)

Principal Display Panel - 4 g Cylinder Blister Pack