DERMAL QUENCH CLEAR ANTI-ACNE TREATMENT- 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 MEDICATION

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.
  • AVOID CONTACT WITH EYES. IF EXCESSIVE SKIN IRRITATION DEVELOPS OR INCREASES, DISCONTINUE USE AND CONSULT A DOCTOR.

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

  • AM/PM, USE 1-3 TIMES DAILY. SHAKE BOTTLE WELL. PRESS ACTUATOR BUTTON TO DISPERSE SMALL AMOUT ONTO FINGERTIPS, APPLY ON AFFECTED AREAS AND MASSAGE INTO SKIN. AVOID CONTACT WITH EYES AND LIPS.

  • DO NOT USE THIS PRODUCT IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO SALICYLIC ACID. 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,A 70 PROPELLANT*, PERFLUOROHEXANE, DIMETHICONE, PROPANEDIOL, ISODODECANE, PERFLUOROPERHYDROPHENANTHRENE, BUTYLENE GLYCOL, PERFLUORODECALIN, GLYCERIN, GLYCERETH-18 ETHYLHEXANOATE, CETEARYL ALCOHOL, CETETH-20 PHOSPHATE, DICETYL PHOSPHATE, TROPAEOLUM MAJUS FLOWER/LEAF/STEM EXTRACT, AVENA SATIVA (OAT) EXTRACT, COCAMIDOPROPYL DIMETHYLAMINE, GLYCERETH-18, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, NEOPENTYL GLYCOL DIHEPTANOATE, PEG-60 ALMONT GLYCERIDES, CAPRYLYL GLYCOL, SODIUM HYDROXIDE, SCLEROTIUM GUM, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, PHOSPHOLIPIDS, POLYSORBATE 80, HYDROLYZED HYALURONIC ACID, BEESWAX/CERA ALBA/CIRE D'ABEILLE, BUTYROSPERMUM PARKII (SHEA) BUTTER EXTRACT, BENZALKONIUM CHLORIDE, CAMELLIA SINENSIS LEAF EXTRACT, PALMITOYL TRIPEPTIDE-5, ASCORBIC ACID, PALMITIC ACID, FUCUS VESICULOSIS EXTRACT, ZINC SULFATE, CLAY, ORYZA SATIVA (RICE) BRAN EXTRACT, BOSWELLIA SERRATA EXTRACT, HONEY EXTRACT/MEL/ EXTRAIT DE MIEL, SIMETHICONE, CARBOMER, OLIGOPEPTIDE-10, NORDIHYDROGUAIARETIC ACID, OLEANOLIC ACID, MELALEUCA ALTERNIFOLIA (TEA TREE) OIL, LITSEA CUBEBA OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, POTASSIUM SORBATE, SODIUM BENZOATE, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, CITRAL, LINALOOL

*PROPELLAN IS AN ISOBUTANE-PROPANE BLEND THAT EVAPORATES WHEN PRODUCT IS EXPELLED FROM CONTAINER, AND DISSIPATES PRIOR TO CONTACT WITH SKIN

DQ CLEAR

DQClear_1 5oz_Primary_LABEL_012714

DERMAL QUENCH CLEAR ANTI-ACNE TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43479-108
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)  
PROPANE (UNII: T75W9911L6)  
ISOBUTANE (UNII: BXR49TP611)  
PERFLEXANE (UNII: FX3WJ41CMX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPANEDIOL (UNII: 5965N8W85T)  
ISODODECANE (UNII: A8289P68Y2)  
PERFLUOROPERHYDROPHENANTHRENE (UNII: ZZ3T53GWV9)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PERFLUNAFENE (UNII: 54A06VV62N)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
TROPAEOLUM MAJUS (UNII: 9G6ZOS4L87)  
OAT (UNII: Z6J799EAJK)  
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
GLYCERETH-18 (UNII: SA5E43C17C)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
HYALURONIC ACID (UNII: S270N0TRQY)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SHEA BUTTER (UNII: K49155WL9Y)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
PALMITIC ACID (UNII: 2V16EO95H1)  
FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
ZINC SULFATE (UNII: 89DS0H96TB)  
KAOLIN (UNII: 24H4NWX5CO)  
RICE BRAN (UNII: R60QEP13IC)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
HONEY (UNII: Y9H1V576FH)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
MASOPROCOL (UNII: 7BO8G1BYQU)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
TEA TREE OIL (UNII: VIF565UC2G)  
LITSEA OIL (UNII: 2XIW34BN6O)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CITRAL (UNII: T7EU0O9VPP)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43479-108-521 in 1 BOX06/22/201411/18/2018
1NDC:43479-108-1245 mL in 1 BOTTLE, PUMP; 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