CLEAR PROOF ACNE SYSTEM- benzoyl peroxide and salicylic acid   
Mary Kay Inc.

Disclaimer: 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.

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Mary Kay
Clear Proof Acne System

Clarifying Cleansing Gel

Drug Facts

Active ingredient

Salicylic Acid (2% W/W)

Purpose

Acne Medication

Uses

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

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

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

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

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.

Other information

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 Type HUMAN OTC DRUG Item Code (Source) NDC:51531-8977
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51531-8977-0 1 in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 28 g
Part 2 1 BOTTLE 147 mL
Part 3 1 TUBE 127 g
Part 4 1 TUBE 88 mL
Part 1 of 4
CLEAR PROOF ACNE TREATMENT  ACNE MEDICATION
benzoyl peroxide gel
Product Information
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLOXAMER 182 (UNII: JX0HIX6OAG)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
CUCUMBER (UNII: YY7C30VXJT)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
ALCOHOL (UNII: 3K9958V90M)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 08/15/2013
Part 2 of 4
CLEAR PROOF BLEMISH CONTROL TONER  ACNE MEDICATION
salicylic acid liquid
Product Information
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
MENTHOL (UNII: L7T10EIP3A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 147 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 08/15/2013
Part 3 of 4
CLEAR PROOF CLARIFYING CLEANSING GEL  ACNE MEDICATION
salicylic acid gel
Product Information
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM C14 OLEFIN SULFONATE (UNII: N816E2SOKI)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GLYCERIN (UNII: PDC6A3C0OX)  
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 127 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 08/15/2013
Part 4 of 4
CLEAR PROOF OIL-FREE MOISTURIZER FOR ACNE-PRONE SKIN 
other skin care preparations
Product Information
Other Ingredients
Ingredient Kind Ingredient Name Quantity
INGR WATER (UNII: 059QF0KO0R)  
INGR GLYCERIN (UNII: PDC6A3C0OX)  
INGR CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGR DIMETHICONE (UNII: 92RU3N3Y1O)  
INGR BETAINE (UNII: 3SCV180C9W)  
INGR STEARIC ACID (UNII: 4ELV7Z65AP)  
INGR ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
INGR PEG-100 STEARATE (UNII: YD01N1999R)  
INGR NIACINAMIDE (UNII: 25X51I8RD4)  
INGR DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
INGR CETYL ALCOHOL (UNII: 936JST6JCN)  
INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
INGR EDETATE DISODIUM (UNII: 7FLD91C86K)  
INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGR PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
INGR TROLAMINE (UNII: 9O3K93S3TK)  
INGR XANTHAN GUM (UNII: TTV12P4NEE)  
INGR PUMPKIN (UNII: SYW0QUB89Y)  
INGR MILK THISTLE (UNII: U946SH95EE)  
INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGR PHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGR SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 88 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 08/15/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 08/15/2013
Labeler - Mary Kay Inc. (103978839)
Establishment
Name Address ID/FEI Business Operations
Mary Kay Inc. 103978839 manufacture(51531-8977)

Revised: 3/2014
Document Id: f69385f2-6e6d-4469-8e71-2183eddbd7a2
Set id: fc1b28a4-a27e-4ae5-b4ac-58927d641168
Version: 1
Effective Time: 20140317
 
Mary Kay Inc.