Your browser does not support JavaScript! CLEAR PROOF ACNE SYSTEM (BENZOYL PEROXIDE AND SALICYLIC ACID) KIT [MARY KAY INC.]
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CLEAR PROOF ACNE SYSTEM (benzoyl peroxide and salicylic acid) kit
[Mary Kay Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Clarifying Cleansing Gel

Drug Facts

Active ingredient

Salicylic Acid (2% W/W)

Purpose

Acne Medication

Uses

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

Warnings

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

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.

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

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

Active ingredient

Salicylic Acid (2% W/W)

Purpose

Acne Medication

Uses

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

Warnings

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

Stop use and ask a doctor if

irritation or sensitivity develops or increases

Keep out of reach of children.

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

Directions

  • 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

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

Acne Treatment Gel

Drug Facts

Active ingredient

Benzoyl Peroxide 5%

Purpose

Acne Medication

Uses

  • for the management of acne
  • dries up acne pimples
  • helps prevent new acne pimples

Warnings

For external use only

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

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.

Stop use and ask a doctor if

irritation becomes severe

Keep out of reach of children.

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

  • 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.

Other information

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

Inactive ingredients

aesculus hippocastanum (horse chestnut) seed extract, alcohol denat., 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

Oil-Free Moisturizer for Acne-Prone Skin

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

image of carton

CLEAR PROOF ACNE SYSTEM 
benzoyl peroxide and salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51531-8977
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51531-8977-01 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 28 g
Part 21 BOTTLE 147 mL
Part 31 TUBE 127 g
Part 41 TUBE 88 mL
Part 1 of 4
CLEAR PROOF ACNE TREATMENT  ACNE MEDICATION
benzoyl peroxide gel
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/15/2013
Part 2 of 4
CLEAR PROOF BLEMISH CONTROL TONER  ACNE MEDICATION
salicylic acid liquid
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
DENATONIUM BENZOATE 
TERT-BUTYL ALCOHOL 
PROPYLENE GLYCOL 
CITRIC ACID MONOHYDRATE 
DOCUSATE SODIUM 
EUCALYPTUS OIL 
MENTHOL 
DIMETHICONE 
SILICON DIOXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1147 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/15/2013
Part 3 of 4
CLEAR PROOF CLARIFYING CLEANSING GEL  ACNE MEDICATION
salicylic acid gel
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM C14 OLEFIN SULFONATE 
COCAMIDOPROPYL BETAINE 
SODIUM CHLORIDE 
TROLAMINE 
EDETATE DISODIUM 
PHENOXYETHANOL 
BUTYLENE GLYCOL 
CITRIC ACID MONOHYDRATE 
PROPYLENE GLYCOL 
METHYLPARABEN 
ETHYLPARABEN 
DMDM HYDANTOIN 
ARCTIUM LAPPA ROOT 
PROPYLPARABEN 
GLYCERIN 
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1127 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/15/2013
Part 4 of 4
CLEAR PROOF OIL-FREE MOISTURIZER FOR ACNE-PRONE SKIN 
other skin care preparations
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRGLYCERIN 
INGRCETEARYL ETHYLHEXANOATE 
INGRBUTYLENE GLYCOL 
INGRMEDIUM-CHAIN TRIGLYCERIDES 
INGRGLYCERYL MONOSTEARATE 
INGRDIMETHICONE 
INGRBETAINE 
INGRSTEARIC ACID 
INGRISOSTEARYL ALCOHOL 
INGRPEG-100 STEARATE 
INGRNIACINAMIDE 
INGRDIAZOLIDINYL UREA 
INGRCETYL ALCOHOL 
INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
INGREDETATE DISODIUM 
INGR.ALPHA.-TOCOPHEROL ACETATE 
INGRPEG-4 LAURATE 
INGRTROLAMINE 
INGRXANTHAN GUM 
INGRPUMPKIN 
INGRMILK THISTLE 
INGRIODOPROPYNYL BUTYLCARBAMATE 
INGRPHENOXYETHANOL 
INGRSODIUM BENZOATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
188 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic08/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/15/2013
Labeler - Mary Kay Inc. (103978839)
Establishment
NameAddressID/FEIBusiness Operations
Mary Kay Inc.103978839manufacture(51531-8977)

Revised: 3/2014
 
Mary Kay Inc.

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