24 HOUR PIMPLE PUNISHER- salicylic acid 
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 INGREDIENT

SALICYLIC ACID 2%

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 MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MY INCREASE DRYNESS OR IRRITATION OF SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.
  • AVOID CONTACT WITH EYES. RINSE WITH WARM WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION DEVELOPS OR INCREASES.

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

DIRECTIONS

  • AM. APPLY BLEMISH CLEARING GEL, BEFORE APPLYING MAKEUP, DIRECTLY ON THE SPOTS TO BE TREATED.
  • PM. APPLY ACNE TREATMENT CLAY, BEFORE BED, DIRECTLY ON BREAKOUTS.

OTHER INFORMATION

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 EVEN FROM USING THIS PRODUCT TO 1-800-984-KATE ON WEEKDAYS 9 A.M.-5 P.M. PT.

INACTIVE INGREDIENTS: WATER, KAOLIN, DI-C12-13 ALKYL MALATE, GLYCERIN, BENTONITE, TRIDECYL SALICYLATE, CETEARYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, TITANIUM DIOXIDE, MONTMORILLONITE, NORDIHYDROGUAIARETIC ACID, SALIX NIGRA (WILLOW) BARK EXTRACT, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF EXTRACT, BAKUCHIOL, ALLANTOIN, BISABOLOL, TOCOPHERYL ACETATE, DIMETHICONE, OLEANOLIC ACID, PEG-6 ALMOND GLYCERIDES, CAPRYLYL GLYCOL, CARBOMER, STEARETH-10, STEARETH-20, BUTYLENE GLYCOL, AMINOMETHYL PROPANOL, XANTHAN GUM, POTASSIUM SORBATE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, DECYLENE GLYCOL, DISODIUM EDTA

PimplePunisherCarton_051414 OL

24 HOUR PIMPLE PUNISHER 
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43479-501
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43479-501-511 in 1 BOX06/22/201411/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 2
Part 1 of 2
PM ACNE TREATMENT CLAY 
salicylic acid cream
Product Information
Item Code (Source)NDC:43479-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
KAOLIN (UNII: 24H4NWX5CO)  
DI-C12-13 ALKYL TARTRATE (UNII: 603USX4K0G)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENTONITE (UNII: A3N5ZCN45C)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MONTMORILLONITE (UNII: A585MN1H2L)  
MASOPROCOL (UNII: 7BO8G1BYQU)  
SALIX NIGRA BARK (UNII: QU52J3A5B3)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
BAKUCHIOL (UNII: OT12HJU3AR)  
ALLANTOIN (UNII: 344S277G0Z)  
LEVOMENOL (UNII: 24WE03BX2T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
STEARETH-10 (UNII: FD0913P475)  
STEARETH-20 (UNII: L0Q8IK9E08)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DECYLENE GLYCOL (UNII: S57M60MI88)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/22/201411/18/2018
Part 2 of 2
AM BLEMISH CLEARING GEL 
lotions, oils, powders, and creams
Product Information
Item Code (Source)NHRIC:43479-901
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRMYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)  
INGRSALIX NIGRA BARK (UNII: QU52J3A5B3)  
INGRMELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
INGRHYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
INGRMASOPROCOL (UNII: 7BO8G1BYQU)  
INGRPEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRCARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
INGRCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
INGROLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
INGRAMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/22/201411/18/2018
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