NDC Code(s) : 55878-102-12
Packager : Halogent, LLC (DBA Exposed Skin Care)

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLARIFYING MASKSULFUR RESORCINOL PASTE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55878-102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFUR(UNII: 70FD1KFU70)
(SULFUR - UNII:70FD1KFU70) 		SULFUR3 g in 100 mL
RESORCINOL(UNII: YUL4LO94HK)
(RESORCINOL - UNII:YUL4LO94HK) 		RESORCINOL2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
KAOLIN(UNII: 24H4NWX5CO)
BENTONITE(UNII: A3N5ZCN45C)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
SESAME OIL(UNII: QX10HYY4QV)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
POLYSORBATE 20(UNII: 7T1F30V5YH)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SORBIC ACID(UNII: X045WJ989B)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
VACCINIUM MYRTILLUS WHOLE(UNII: EE76EZ4QNZ)
MACROCYSTIS PYRIFERA(UNII: K31S3OG5C4)
CARBOMER 940(UNII: 4Q93RCW27E)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
IMIDUREA(UNII: M629807ATL)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
JOJOBA OIL(UNII: 724GKU717M)
SUNFLOWER OIL(UNII: 3W1JG795YI)
HYDROGENATED POLYDECENE (550 MW)(UNII: U333RI6EB7)
SODIUM POLYACRYLATE (8000 MW)(UNII: 285CYO341L)
THIOCTIC ACID, (+)-(UNII: VLL71EBS9Z)
DEANOL(UNII: 2N6K9DRA24)
CERAMIDE 3(UNII: 4370DF050B)
HYALURONIC ACID(UNII: S270N0TRQY)
COLLAGEN, SOLUBLE, FISH SKIN(UNII: 8JC99XGU4W)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55878-102-1250 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 02/07/2013

LABELER - Halogent, LLC (DBA Exposed Skin Care) (790961697)

PRINCIPAL DISPLAY PANEL

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