NDC 0573-0768-39
API & Excipient Details

marketed by Haleon US Holdings LLC under NDC Code 0573-0768-39

NDC Code(s) : 0573-0768-12, 0573-0768-39, 0573-0768-40, 0573-0768-51
Packager : Haleon US Holdings LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Chapstick Moisturizer Cool Mintavobenzone, octinoxate, and white petrolatum STICK

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-0768
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE(UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g
PETROLATUM(UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	414 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CETYL ALCOHOL(UNII: 936JST6JCN)
.ALPHA.-TOCOPHEROL LINOLEATE, D-(UNII: G0N132Q0ED)
ISOCETYL STEARATE(UNII: 3RJ7186O9W)
LANOLIN(UNII: 7EV65EAW6H)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
MINERAL OIL(UNII: T5L8T28FGP)
PARAFFIN(UNII: I9O0E3H2ZE)
SACCHARIN(UNII: FST467XS7D)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
WHITE WAX(UNII: 7G1J5DA97F)

Product Characteristics
Color	YELLOW	Score
Shape	BULLET	Size	42 mm
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0573-0768-12	1 in 1 BLISTER PACK	28/06/2018
1		4 g in 1 CYLINDER Type 0: Not a Combination Product
2	NDC:0573-0768-39	3 in 1 BLISTER PACK	28/06/2018
2		4 g in 1 CYLINDER Type 0: Not a Combination Product
3	NDC:0573-0768-40	3 in 1 BLISTER PACK	28/06/2018
3		4 g in 1 CYLINDER Type 0: Not a Combination Product
4	NDC:0573-0768-51	4 g in 1 CYLINDER Type 0: Not a Combination Product	28/06/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	06/28/2018

LABELER - Haleon US Holdings LLC(079944263)

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