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  5. Label Information: Mark. Break Out Plan

FDA Label for Mark. Break Out Plan

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. WARNINGS
    4. OTC - WHEN USING
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. OTC - QUESTIONS

Mark. Break Out Plan Product Label

The following document was submitted to the FDA by the labeler of this product Avon Products 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.

Otc - Active Ingredient



See attached 1092906 breakout plan FC.jpg


Active ingredient                              Purpose
Salicylic Acid 1.5%....................................Acne Treatment


Indications & Usage



Uses

  • helps in the treatment of acne
  • helps prevent new acne blemishes from forming
  • clears up acne blemishes
  • penetrates pores to eliminate most blackheads and acne pimples



Warnings



Warnings
For external use only


Otc - When Using



When using this product

  • avoid contact with eyes. If product contacts eyes, rinse thoroughly with water. If irritation persists, seek medical attention
  • using other topical acne products at the same time or immediately after use of this product may increase dryness or irritation of the skin.  If this occurs, only one product should be used unless directed by a doctor.

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 medication
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to 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

Inactive Ingredient



Inactive/Non-medicinal ingredients

WATER/EAU
     SD ALCOHOL 40-B
     DIMETHICONE
     POLYSORBATE 20     
     GLYCERIN
     PYRUS MALUS (APPLE) FRUIT EXTRACT
     VANILLA PLANIFOLIA FRUIT EXTRACT
     ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT
     MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT
     SPIRAEA ULMARIA EXTRACT
     CINNAMOMUM CASSIA BARK EXTRACT
     CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT
     HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
     ISOHEXADECANE
     XANTHAN GUM
     TRIMETHYLSILOXYSILICATE
     POLYMETHYL METHACRYLATE
     SILICA
     POLYSORBATE 60
     TALC
     SORBITAN ISOSTEARATE
     CAPRYLIC/CAPRIC TRIGLYCERIDE
     ISOPROPYL MYRISTATE
     DIPROPYLENE GLYCOL
     PYRIDOXINE HCL
     DISODIUM EDTA
     BENZYL ALCOHOL


Otc - Questions



Questions? Call 1-800-meetmark


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