NDC Code 43419-405-34 | pharmacompass.com

NDC Code(s) : 43419-404-34, 43419-405-34
Packager : AMOREPACIFIC CORPORATION

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE AIR CUSHION Cover 21 VanillaZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43419-404
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE(UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g in 30 g
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 g in 30 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.245 g in 30 g

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
PROPANEDIOL(UNII: 5965N8W85T)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
NIACINAMIDE(UNII: 25X51I8RD4)
GLYCERIN(UNII: PDC6A3C0OX)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
DIMETHICONE(UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
ADENOSINE(UNII: K72T3FS567)
TREHALOSE(UNII: B8WCK70T7I)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
POLY(METHYL METHACRYLATE; 450000 MW)(UNII: Z47NNT4J11)
PIDOLIC ACID(UNII: SZB83O1W42)
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
STANNIC OXIDE(UNII: KM7N50LOS6)
GLYCINE(UNII: TE7660XO1C)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
UREA(UNII: 8W8T17847W)
SODIUM GLYCEROPHOSPHATE(UNII: RCS9EQ01V4)
SERINE(UNII: 452VLY9402)
GLUTAMIC ACID(UNII: 3KX376GY7L)
POTASSIUM MAGNESIUM ASPARTATE(UNII: 55TUI7Q42I)
LEUCINE(UNII: GMW67QNF9C)
ALANINE(UNII: OF5P57N2ZX)
LYSINE(UNII: K3Z4F929H6)
ARGININE(UNII: 94ZLA3W45F)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
MAGNESIUM GLUCONATE(UNII: T42NAD2KHC)
TYROSINE(UNII: 42HK56048U)
PHENYLALANINE(UNII: 47E5O17Y3R)
PROLINE(UNII: 9DLQ4CIU6V)
THREONINE(UNII: 2ZD004190S)
VALINE(UNII: HG18B9YRS7)
ISOLEUCINE(UNII: 04Y7590D77)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
HISTIDINE(UNII: 4QD397987E)
N-ACETYLGLUCOSAMINE(UNII: V956696549)
CREATINE(UNII: MU72812GK0)
URIC ACID(UNII: 268B43MJ25)
CYSTEINE(UNII: K848JZ4886)
METHIONINE(UNII: AE28F7PNPL)
PANCRELIPASE LIPASE(UNII: 8MYC33932O)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43419-404-34	1 in 1 POUCH	01/10/2018
1		15 g in 1 CONTAINER Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/10/2018

IOPE AIR CUSHION Cover 23 BeigeZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:43419-405
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE(UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.94 g in 30 g
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.1 g in 30 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.245 g in 30 g

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
PROPANEDIOL(UNII: 5965N8W85T)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
NIACINAMIDE(UNII: 25X51I8RD4)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GLYCERIN(UNII: PDC6A3C0OX)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
DIMETHICONE(UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
ADENOSINE(UNII: K72T3FS567)
TREHALOSE(UNII: B8WCK70T7I)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
POLY(METHYL METHACRYLATE; 450000 MW)(UNII: Z47NNT4J11)
PIDOLIC ACID(UNII: SZB83O1W42)
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
DEXTROSE, UNSPECIFIED FORM(UNII: IY9XDZ35W2)
STANNIC OXIDE(UNII: KM7N50LOS6)
GLYCINE(UNII: TE7660XO1C)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
UREA(UNII: 8W8T17847W)
SODIUM GLYCEROPHOSPHATE(UNII: RCS9EQ01V4)
SERINE(UNII: 452VLY9402)
GLUTAMIC ACID(UNII: 3KX376GY7L)
POTASSIUM MAGNESIUM ASPARTATE(UNII: 55TUI7Q42I)
LEUCINE(UNII: GMW67QNF9C)
ALANINE(UNII: OF5P57N2ZX)
LYSINE(UNII: K3Z4F929H6)
ARGININE(UNII: 94ZLA3W45F)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
MAGNESIUM GLUCONATE(UNII: T42NAD2KHC)
TYROSINE(UNII: 42HK56048U)
PHENYLALANINE(UNII: 47E5O17Y3R)
PROLINE(UNII: 9DLQ4CIU6V)
THREONINE(UNII: 2ZD004190S)
VALINE(UNII: HG18B9YRS7)
ISOLEUCINE(UNII: 04Y7590D77)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
HISTIDINE(UNII: 4QD397987E)
N-ACETYLGLUCOSAMINE(UNII: V956696549)
CREATINE(UNII: MU72812GK0)
URIC ACID(UNII: 268B43MJ25)
CYSTEINE(UNII: K848JZ4886)
METHIONINE(UNII: AE28F7PNPL)
PANCRELIPASE LIPASE(UNII: 8MYC33932O)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43419-405-34	1 in 1 POUCH	01/10/2018
1		15 g in 1 CONTAINER Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/10/2018

NDC 43419-405-34
API & Excipient Details

marketed by AMOREPACIFIC CORPORATION under NDC Code 43419-405-34

NDC Code(s) : 43419-404-34, 43419-405-34
Packager : AMOREPACIFIC CORPORATION

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 43419-405-34 API & Excipient Details

marketed by AMOREPACIFIC CORPORATION under NDC Code 43419-405-34

NDC Code(s) : 43419-404-34, 43419-405-34Packager : AMOREPACIFIC CORPORATION

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 43419-405-34
API & Excipient Details

NDC Code(s) : 43419-404-34, 43419-405-34
Packager : AMOREPACIFIC CORPORATION