Clear Proof Acne System Kit
FDA Label NDC 51531-8977

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mary Kay Inc. for the product Clear Proof Acne System (NDC 51531-8977). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding clarifying cleansing gel, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep our of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Clarifying Cleansing Gel

Drug Facts

Active Ingredient

Salicylic Acid (2% W/W)

Salicylic Acid (2% W/W)

Benzoyl Peroxide 5%

Purpose

Acne Medication

Acne Medication

Acne Medication

Uses

  • for the management of acne
  • reduces the number of blackheads and acne pimples
  • helps prevent new acne pimples
    • for the management of acne
    • reduces the number of blackheads and acne pimples
    • helps prevent new acne pimples
      • for the management of acne
      • dries up acne pimples
      • helps prevent new acne pimples

Warnings

For external use only

For external use only

For external use only

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 contact with the eyes

    • 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 contact with the eyes
      • 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.

Stop Use And Ask A Doctor If

irritation or sensitivity develops or occurs

irritation or sensitivity develops or increases

irritation becomes severe

Keep Our Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • cleanse skin thoroughly before applying medication
  • cover the entire affected area with a thin layer then rinse thoroughly 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
    • cleanse 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

Inactive Ingredients

arctium lappa root extract, butylene glycol, citric acid, cocamidopropyl betaine, cystoseira amentacea/caespitosa branchycarpa extract, disodium EDTA, DMDM hydantoin, epilobium angustifolium flower/leaf/stem extract, ethylparaben, glycerin, methylparben, phenoxyethanol, propylene glycol, propylparaben, sodium C14-16 olefin sulfonate, sodium chloride, triethanolamine, water

alcohol denat., citric acid, diethylhexyl sodium sulfosuccinate, eucalyptus globulus leaf oil, menthol, propylene glycol, simethicone, water

aesculus hippocastanum (horse chestnut) seed extract, butylene glycol, carbomer, cucumis sativus (cucumber) fruit extract, diethylhexyl sodium sulfosuccinate, disodium EDTA, echinacea purpurea extract, glycerin, poloxamer 182, propylene glycol, silica, sodium hydroxide, water

Blemish Control Toner

Drug Facts

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If swallowed, get medical help or contact a Poison Control Center right away.

Acne Treatment Gel

Drug Facts

Do Not Use If You

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Other Information

  • store at 59° F to 86° F
  • expiration date on tube crimp

Ingredients:

Water/Eau, Glycerin, Cetearyl Ethylhexanoate, Butylene Glycol, Caprylic/Capric Triglyceride, Glyceryl Stearate, Dimethicone, Isostearyl Alcohol, Stearic Acid, Betaine, Niacinamide, PEG-100 Stearate, Cetyl Alcohol, Cucurbita Pepo (Pumpkin) Fruit Extract, Silybum Marianum Fruit Extract, Tocopheryl Acetate, Lactobacillus/Ganoderma Lucidum (Reishi) Extract/Lentinus Edodes (Truncated), PEG-4 Laurate, Triethanolamine, Xanthan Gum, Carbomer, Disodium EDTA, Iodopropynyl Butylcarbamate, Phenoxyethanol, Diazolidinyl Urea, Sodium Benzoate

Principal Display Panel - Kit Carton

clear proof acne system

clarifying cleansing gel salicylic acid acne medication 4.5 OZ. NET WT. / 127 g

blemish control toner salicylic acid acne medication liquid 5 FL. OZ. / 147 ml

acne treatment gel benzoyl peroxide acne medication 1 OZ. NET WT. / 28 g

oil-free moisturizer for acne-prone skin 3 FL. OZ. / 88 ml

* Please review the disclaimer below.