HYDRACLEAR HYDRATING ACNE- salicylic acid gel 
KATE SOMERVILLE SKINCARE, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS

SALICYLIC ACID- 0.5%

PURPOSE

ACNE TREATMENT

USES

  • FOR THE TREATMENT OF ACNE
  • HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

  • USING OTHER TOPICAL  ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

KEEP OUT OF REACH OF CHILDREN.

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

DIRECTIONS

  • AM AND PM
  • CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICATION
  • COVER ENTIRE AFFECTED AREA WITH A THIN LAYER, ONE TO THREE TIMES DAILY

  • PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.
  • YOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-984-KATE ON WEEKDAYS 9 A.M.-5 P.M. PT

INACTIVE INTREDIENTS

WATER/AQUA/EAU, GLYCERIN, GLYCERETH-7, TRIMETHYL ETHER, BUTYLENE GLYCOL, PVM/MA DECADIENE CROSSPOLYMER, POLYSORBATE 20, PHYTIC ACID, EPILOBIUM ANGUSTIFOLIUM FLOWER/LEAF/STEM EXTRACT, AVENA SATIVA (OAT) KERNEL EXTRACT, NORDIHYDROGUAIARETIC ACID, OLEANOLIC ACID, BIOTIN, CHONDRUS CRISPUS EXTRACT, SODIUM HYALURONATE, ALOE BARBADENSIS LEAF JUICE, PEG-60 ALMOND GLYCERIDES, CAPRYLYL GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL, JASMINUM SAMBAC (JASMINE) FLOWER EXTRACT, LAVANDULA HYBRIDA OIL, CYMBOPOGON SCHOENANTHUS OIL, EUCALYPTUS RADIATA FLOWER/LEAF/STEM OIL, CISTUS LADANIFERUS RESIN, ETHYLHEXYLGLYCERIN, SALVIA SCLAREA (CLARY) OIL, BULNESIA SARMIENTOI WOOD OIL, CITRUS RETICULATA (TANGERINE) LEAF OIL, JUNIPERUS VIRGINIANA OIL, GLUCONOLACTONE, CITRUS AURANTIFOLIA (LIME) PEEL OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT EXTRACT, SODIUM METABISULFITE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, CITRUS LIMON (LEMON) PEEL OIL, VETIVERIA ZIZANOIDES ROOT OIL, MENTHOL EVERNIA FURFURACEA (TREEMOSS) EXTRACT, CARBOMER, DISODIUM EDTA, PHENOXYETHANOL, SODIUM HYDROXIDE.

HydraClear_Carton_101013OL

HYDRACLEAR HYDRATING ACNE 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43479-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERETH-7 TRIMETHYL ETHER (UNII: XMC7402M60)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
FYTIC 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)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43479-107-521 in 1 BOX06/22/201411/18/2018
1NDC:43479-107-1260 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/22/201411/18/2018
Labeler - KATE SOMERVILLE SKINCARE, LLC (615155533)

Revised: 11/2018
 
KATE SOMERVILLE SKINCARE, LLC