NDC Code(s) : 46783-004-15, 46783-004-20, 46783-004-04, 46783-004-30
Packager : Merz North America

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AFTER CAREDIMETHICONE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46783-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
OCTYLDODECANOL(UNII: 461N1O614Y)
PETROLATUM(UNII: 4T6H12BN9U)
HYDROGENATED POLYISOBUTENE (1300 MW)(UNII: 7D1YQ9Y5EZ)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
DECYL OLEATE(UNII: ZGR06DO97T)
GLYCERIN(UNII: PDC6A3C0OX)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WHEAT GERM OIL(UNII: 14C97E680P)
STEARIC ACID(UNII: 4ELV7Z65AP)
CETYL ALCOHOL(UNII: 936JST6JCN)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
HUMAN SKIN PROTEINS, PARTIALLY HYDROLYZED(UNII: G9813R29TW)
MYRETH-3 MYRISTATE(UNII: O2C2MN32O6)
CETEARETH-12(UNII: 7V4MR24V5P)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETYL PALMITATE(UNII: 5ZA2S6B08X)
DIOSCOREA VILLOSA TUBER(UNII: IWY3IWX2G8)
BORAGE SEED OIL(UNII: F8XAG1755S)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE(UNII: 0A5MM307FC)
METHYLPARABEN(UNII: A2I8C7HI9T)
METHYLPARABEN SODIUM(UNII: CR6K9C2NHK)
ETHYLPARABEN(UNII: 14255EXE39)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46783-004-151 in 1 CARTON 04/01/2019
115 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:46783-004-201 in 1 CARTON 04/01/2019
2200 mL in 1 BOTTLE Type 0: Not a Combination Product
3NDC:46783-004-044 mL in 1 TUBE Type 0: Not a Combination Product06/11/2019
4NDC:46783-004-301 in 1 CARTON 10/02/2023
430 mL in 1 BOTTLE Type 0: Not a Combination Product06/11/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph drug M016 04/01/2019

LABELER - Merz North America(028147846)

PRINCIPAL DISPLAY PANEL

aftercare

POST-TREATMENT
SOOTHING CREAM

NEOCUTIS®

PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton