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EradiKate Facial Mask

Dosage form: lotion
Ingredients: SULFUR 5g in 100mL
Labeler: Kate Somerville Skincare, LLC
NDC Code: 43479-109

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 INGREDIENTS:

SULFUR, 5%

PURPOSE

ACNE TREATMENT

USES

  • FOR THE TRETAMENT 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

  • CLEANSE SKIN THOROUGHLY BEFORE APPLYING. COVER THE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES A DAY. BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH 1 APPLICATION DAILY, THEN GRADUALLY INCREASE TO 2 OR 3 TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.

OTHER INFORMATION

  • DO NOT USE THIS PRODUCT IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO SULFUR.
  • YOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-981-KATE ON WEEKDAYS 9A.M.-5P.M. PACIFIC TIME.

INACTIVE INGREDIENT

Acrylates Copolymer, Avena Sativa (Oat) Extract, Behenyl Alcohol, Boswellia Serrata Extract, Butylene Glycol, Cetearyl Alcohol, Citric Acid, Cocamidopropyl Hydroxysultaine, Coco Glucoside, Disodium Carboxyethyl Siliconate, Disodium EDTA, Ethyl Perfluorobutyl Ether, Ethyl Perfluoroisobutyl Ether, Ethylhexylglycerin, Fragrance (Parfum), Glycereth-18, Glycereth-18 Ethylhexanoate, Glycerin, Honey (Mel) Extract, Iron Oxide (CI 77491), Oligopeptide-10, Oryza Sativa (Rice) Bran Extract, Phenoxyethanol, Potassium Sorbate, Propanediol, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Sodium Cocoamphoacetate, Sodium Hydroxide, Stearyl Alcohol, Titanium Dioxide (CI 77891), Water/Aqua/Eau, Xanthan Gum

ERADIKATE FACIAL MASK 
sulfur lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43479-109
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (SULFUR) SULFUR5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
XANTHAN GUM 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
GLYCERETH-18 
GLYCERETH-18 ETHYLHEXANOATE 
SODIUM C14-16 OLEFIN SULFONATE 
SODIUM COCOAMPHOACETATE 
COCAMIDOPROPYL HYDROXYSULTAINE 
PROPANEDIOL 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
SODIUM CHLORIDE 
FERRIC OXIDE RED 
DISODIUM CARBOXYETHYL SILICONATE 
EDETATE DISODIUM 
COCO GLUCOSIDE 
CETOSTEARYL ALCOHOL 
DOCOSANOL 
STEARYL ALCOHOL 
SODIUM HYDROXIDE 
AVENA SATIVA WHOLE 
GLYCERIN 
POTASSIUM SORBATE 
BUTYLENE GLYCOL 
RICE BRAN 
BOSWELLIA SERRATA WHOLE 
HONEY 
PALMITOYL OLIGOPEPTIDE 
SODIUM BENZOATE 
ANHYDROUS CITRIC ACID 
ETHYL PERFLUOROBUTYL ETHER 
ETHYL PERFLUOROISOBUTYL ETHER 
Packaging
#Item CodePackage Description
1NDC:43479-109-541 TUBE in 1 BOX
1NDC:43479-109-1430 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/15/2014
Labeler - Kate Somerville Skincare, LLC (615155533)

Revised: 06/2014
 
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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