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  5. Label Information: O Skin Acne Moderate

FDA Label for O Skin Acne Moderate

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USE:
    4. DIRECTIONS:
    5. WARNINGS:
    6. OTC - DO NOT USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. OTHER INFORMATION.
    9. INACTIVE INGREDIENTS:
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

O Skin Acne Moderate Product Label

The following document was submitted to the FDA by the labeler of this product O Skin Care 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.

Active Ingredients



BENZOYL PEROXIDE  5%


Purpose



ACNE TREATMENT


Use:



FOR THE TREATMENT OF ACNE


Directions:



CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT. PAT A THIN LAYER TO AFFECTED AREA DAILY MORNING AND NIGHT AND ALLOW TO DRY.

  • BECAUSE EXCESSIVE DRYING MAY OCCUR, START WITH ONCE DAILY APPLICATION.
  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO EVERY OTHER DAY.

Warnings:



FOR EXTERNAL USE ONLY.


Otc - Do Not Use



DO NOT USE THIS PRODUCT IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE. THIS PRODUCT MAY CAUSE IRRITATION.

ASK A PHYSICIAN OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A PHYSICIAN. AVOID UNNECESSARY SUN EXPOSURE. USE A SUNSCREEN WHILE USING THIS PRODUCT AND FOR A WEEK AFTERWARDS.

STOP USE AND ASK A PHYSICIAN IF SKIN IRRITATION OCCURS, AND BECOMES SEVERE.


Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN. KEEP AWAY FROM LIPS AND MOUTH. IF SWALLOWED, GET MEDICAL HELP OR CONTACT THE POISON CONTROL CENTER RIGHT AWAY.


Other Information.



THIS PRODUCT MAY BLEACH HAIR OR DYE FABRICS. AVOID STORING AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).


Inactive Ingredients:



DEIONIZED WATER, PROPYLENE GLYCOL, CARBOMER 940, SODIUM HYDROXIDE, CPE 722.


* Please review the disclaimer below.