1. Home
  2. Labeler Index
  3. Kate Somerville Skincare, Llc
  4. 43479-106
  5. Label Information: Eradikate Acne Treatment

FDA Label for Eradikate Acne Treatment

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. OTHER SAFETY INFORMATION
    10. INACTIVE INGREDIENT
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eradikate Acne Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Kate Somerville Skincare, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



ACTIVE INGREDIENTS:

SULFUR, 10%


Otc - Purpose



PURPOSE

ACNE TREATMENT


Indications & Usage



USES

  • FOR THE TRETAMENT OF ACNE
  • HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES

Warnings



WARNINGS

FOR EXTERNAL USE ONLY


Otc - When Using



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.

Otc - Stop Use



STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS.


Otc - Keep Out Of Reach Of Children



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


Dosage & Administration



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 Safety Information



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



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)


Package Label.Principal Display Panel




* Please review the disclaimer below.