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  5. Label Information: Benzoil 12hr Acne Treatment

FDA Label for Benzoil 12hr Acne Treatment

View Indications, Usage & Precautions

Table of Contents

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

Benzoil 12hr Acne Treatment Product Label

The following document was submitted to the FDA by the labeler of this product The Skincare Company, Inc.. 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.

Active Ingredient



BENZOYL PEROXIDE 3%


Purpose



ACNE TREATMENT


Use



FOR THE TREATMENT OF ACNE.


Warnings



FOR EXTERNAL USE ONLY


Otc - When Using



WHEN USING THIS PRODUCT

  • SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME. IF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.
  • AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH.
  • AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT.
  • SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING, OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.

Otc - Stop Use



STOP USE AND ASK A DOCTOR IF

  • IRRITATION BECOMES SEVERE.

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.


Directions



  • SENSITIVITY TEST FOR A NEW USER. APPLY PRODUCT SPARINGLY TO ONE OR TWO SMALL AFFECTED AREAS DURING THE FIRST 3 DAYS. IF NO DISCOMFORT OCCURS, FOLLOW THE DIRECTIONS STATED BELOW.
  • CLEAN THE SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT.
  • COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY.
  • BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO OR THREE 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.
  • IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USE OF BOTH PRODUCTS AND ASK A DOCTOR.

Other Information



  • ORGANIC INGREDIENTS ARE DENOTED WITH THE * SYMBOL
  • STORE AT 4-25°c (39-77°f), OUT OF DIRECT SUNLIGHT

Inactive Ingredients



ALCOHOL*, DIMETHYL ISOSORBIDE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL*, RICINUS COMMUNIS (CASTOR) SEED OIL*, WATER, XANTHAN GUM


Package Label.Principal Display Panel



Benzoil_UC - Benzoil UC

Benzoil_UC - Benzoil UC


* Please review the disclaimer below.