NDC Code(s) : 43479-107-12, 43479-107-52
Packager : KATE SOMERVILLE SKINCARE, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

HYDRACLEAR HYDRATING ACNE GELSALICYLIC ACID GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43479-107
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID0.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERETH-7 TRIMETHYL ETHER(UNII: XMC7402M60)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PVP/VA COPOLYMER(UNII: D9C330MD8B)
POLYSORBATE 20(UNII: 7T1F30V5YH)
PHYTIC ACID(UNII: 7IGF0S7R8I)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP(UNII: 08H094218D)
OAT(UNII: Z6J799EAJK)
MASOPROCOL(UNII: 7BO8G1BYQU)
OLEANOLIC ACID(UNII: 6SMK8R7TGJ)
BIOTIN(UNII: 6SO6U10H04)
CHONDRUS CRISPUS(UNII: OQS23HUA1X)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
PEG-60 ALMOND GLYCERIDES(UNII: 4Y0E651N0F)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
TOCOPHEROL(UNII: R0ZB2556P8)
JASMINUM SAMBAC FLOWER(UNII: 2S686I937F)
LAVANDIN OIL(UNII: 9RES347CKG)
CYMBOPOGON SCHOENANTHUS OIL(UNII: XE7K568ILO)
EUCALYPTUS RADIATA FLOWERING TOP OIL(UNII: C7YKX126BI)
CISTUS LADANIFER RESIN(UNII: 0RCR3SP5VE)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
CLARY SAGE OIL(UNII: 87L0D4U3M0)
BULNESIA SARMIENTOI WOOD OIL(UNII: 81H0L6W02F)
CITRUS RETICULATA LEAF OIL(UNII: 1515UE78IH)
JUNIPERUS VIRGINIANA OIL(UNII: PAD4FN7P2G)
GLUCONOLACTONE(UNII: WQ29KQ9POT)
LIME OIL(UNII: UZH29XGA8G)
BERGAMOT OIL(UNII: 39W1PKE3JI)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
ORANGE OIL(UNII: AKN3KSD11B)
LEMON OIL(UNII: I9GRO824LL)
VETIVER OIL(UNII: 9M9P32M01L)
MENTHOL(UNII: L7T10EIP3A)
PSEUDEVERNIA FURFURACEA(UNII: 49ZMN09Q0K)
CARBOMER 940(UNII: 4Q93RCW27E)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43479-107-521 in 1 BOX
1NDC:43479-107-1260 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 06/22/2014

PRINCIPAL DISPLAY PANEL

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