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24 HOUR PIMPLE PUNISHER

Medically reviewed on June 22, 2018

Dosage form: kit
Ingredients: SALICYLIC ACID 2g in 100mL;
Labeler: KATE SOMERVILLE SKINCARE, LLC
NDC Code: 43479-501

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.

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

Established Pharmacological Class
SubstancePharmacological Class
AM BLEMISH CLEARING GELLotions, Oils, Powders, and Creams
24 HOUR PIMPLE PUNISHER 
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43479-501
Packaging
#Item CodePackage Description
1NDC:43479-501-511 KIT in 1 BOX
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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
KAOLIN 
DI-C12-13 ALKYL TARTRATE 
GLYCERIN 
BENTONITE 
TRIDECYL SALICYLATE 
CETOSTEARYL ALCOHOL 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
TITANIUM DIOXIDE 
MONTMORILLONITE 
MASOPROCOL 
SALIX NIGRA BARK 
MELALEUCA ALTERNIFOLIA LEAF 
BAKUCHIOL 
ALLANTOIN 
LEVOMENOL 
.ALPHA.-TOCOPHEROL ACETATE 
DIMETHICONE 
OLEANOLIC ACID 
APRICOT KERNEL OIL PEG-6 ESTERS 
CAPRYLYL GLYCOL 
CARBOMER 940 
STEARETH-10 
STEARETH-20 
BUTYLENE GLYCOL 
AMINOMETHYLPROPANOL 
XANTHAN GUM 
POTASSIUM SORBATE 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
DECYLENE GLYCOL 
EDETATE DISODIUM 
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/22/2014
Part 2 of 2
AM BLEMISH CLEARING GEL 
Product Information
Item Code (Source)43479-901
Ingredients
Ingredient NameQuantity
WATER 
PENTYLENE GLYCOL 
GLYCERIN 
BUTYLENE GLYCOL 
MYRISTOYL PENTAPEPTIDE-4 
SALIX NIGRA BARK 
MELALEUCA ALTERNIFOLIA LEAF 
HYDROXYPHENYL PROPAMIDOBENZOIC ACID 
MASOPROCOL 
PEG-60 ALMOND GLYCERIDES 
CAPRYLYL GLYCOL 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CARBOMER 940 
OLEANOLIC ACID 
AMINOMETHYLPROPANOL 
EDETATE DISODIUM 
POTASSIUM SORBATE 
ETHYLHEXYLGLYCERIN 
PHENOXYETHANOL 
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/22/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/22/2014
Labeler - KATE SOMERVILLE SKINCARE, LLC (615155533)

 
KATE SOMERVILLE SKINCARE, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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