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EradiKate ACNE TREATMENT

Medically reviewed on June 23, 2017.

Dosage form: liquid
Ingredients: SULFUR 10g in 100mL
Labeler: Kate Somerville Skincare, LLC
NDC Code: 43479-106

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, 10%

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

ISOPROPYL ALCOHOL, WATER/AQUA/EAU, CAMPHOR, MAGNESIUM ALUMINUM SILICATE, SALICYLIC ACID, IRON OXIDES (CI 77489, CI 77491, CI 77492, CI 77499), ZINC OXIDE (CI 77947)

ERADIKATE ACNE TREATMENT 
sulfur liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43479-106
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (SULFUR) SULFUR10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
WATER 
CAMPHOR (NATURAL) 
MAGNESIUM ALUMINUM SILICATE 
SALICYLIC ACID 
FERROUS OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
ZINC OXIDE 
Packaging
#Item CodePackage Description
1NDC:43479-106-511 BOTTLE, GLASS in 1 BOX
1NDC:43479-106-1130 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/15/2014
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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