Mary Kay

Mary Kay
SPL v7
SPL
SPL Set ID fc1b28a4-a27e-4ae5-b4ac-58927d641168
Route
TOPICAL
Published
Effective Date 2020-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (5 g) Salicylic Acid (2 g)
Inactive Ingredients
Water Propylene Glycol Poloxamer 182 Silicon Dioxide Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Sodium Hydroxide Docusate Sodium Edetate Disodium Glycerin Butylene Glycol Echinacea Purpurea Cucumber Horse Chestnut Alcohol Denatonium Benzoate Tert-butyl Alcohol Citric Acid Monohydrate Eucalyptus Oil Menthol Dimethicone Methylparaben Ethylparaben Dmdm Hydantoin Arctium Lappa Root Propylparaben Epilobium Angustifolium Flowering Top Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Sodium Chloride Trolamine Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-08-15

Description

Drug Facts

Purpose

Acne Medication


Medication Information

Purpose

Acne Medication

Dosage and Administration
  • 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
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Description

Drug Facts

Uses
  • for the management of acne
  • reduces the number of blackheads and acne pimples
  • helps prevent new acne pimples
Warnings

For external use only

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
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

Active Ingredient

Salicylic Acid (2% W/W)

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
Acne Treatment Gel

Drug Facts

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

Blemish Control Toner

Drug Facts

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

Clarifying Cleansing Gel

Drug Facts

Stop Use and Ask A Doctor If

irritation or sensitivity develops or occurs

Keep Our of Reach of Children.

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

Keep Out of Reach of Children.

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

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


Structured Label Content

Uses
  • for the management of acne
  • reduces the number of blackheads and acne pimples
  • helps prevent new acne pimples
Dosage and Administration (34068-7)
  • 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
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Purpose

Acne Medication

Warnings

For external use only

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
Ingredients: (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

Active Ingredient (Active ingredient)

Salicylic Acid (2% W/W)

Do Not Use If You (Do not use if you)
  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Other Information (Other information)
  • store at 59° F to 86° F
  • expiration date on tube crimp
Acne Treatment Gel

Drug Facts

Inactive Ingredients (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

Blemish Control Toner

Drug Facts

When Using This Product (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

Clarifying Cleansing Gel

Drug Facts

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation or sensitivity develops or occurs

Keep Our of Reach of Children. (Keep our of reach of children.)

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

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.

Principal Display Panel Kit Carton (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


Advanced Ingredient Data


Raw Label Data

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