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  5. Label Information: Anti Bac Acne Clearing

FDA Label for Anti Bac Acne Clearing

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 INFORMATION
    10. INACTIVE INGREDIENTS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anti Bac Acne Clearing 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 INGREDIENT

BENZOYL PEROXIDE- 5%


Otc - Purpose



PURPOSE

ACNE TREATMENT


Indications & Usage



USE

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


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.
  • DO NOT USE THIS PRODUCT IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.
  • AVOID CONTACT WITH EYES, LIPS, AND MOUTH.
  • AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT.
  • SKIN IRRITATION MY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING, OR POSSIBLE SWELLING. IRRITATION MY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.

Otc - Stop Use



STOP USE AND ASK A DOCTOR IF SKIN IRRITATION BECOMES SEVERE.


Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS 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, REDUCT APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.
  • IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USE OF PRODUCTS AND ASK A DOCTOR.


Other Information



  • YOU MAY REPORT A SERIOUS ADVERSE REACTION FROM USING THIS PRODUCT TO 1-800-984-KATE ON WEEKDAYS 9 A.M.-5 P.M. PT


Inactive Ingredients



WATER/AQUA/EAU, PPG-2 MYRISTYL ETHER PROPIONATE, ARGANIA SPINOSA KERNEL EXTRACT, PEG-40 STEARATE, SERENOA SERRULATA FRUIT EXTRACT, SESAMUM INDICUM (SESAME) SEED EXTRACT, ALCOHOL DENAT., SORBITAN STEARATE, HYDROGENATED METHYL ABEITATE, METHYL METHACRYLATE CROSSPOLYMER, CARBOMER, GLYCERYL STEARATE, CETYL ALCOHOL, TETRASODIUM EDTA, HYDROGENATED LECITHIN, CHOLESTEROL, CERAMIDE NS, CERAMIDE NP, OLEIC ACID, PALMITIC ACID, SODIUM ASCORBATE, SODIUM HYDROXIDE, EDTA, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL


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