CLEAR PROOF ACNE SYSTEM- benzoyl peroxide and salicylic acid kit

Clear Proof Acne System by

Drug Labeling and Warnings

Clear Proof Acne System by is a Otc medication manufactured, distributed, or labeled by Mary Kay Inc., Port Jervis Laboratories Inc., Komplete Group Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

DOSAGE & 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.

Other information

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

Inactive ingredients

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

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

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

INGREDIENTS AND APPEARANCE

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	08/15/2013

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

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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		28 g in 1 TUBE; Type 0: Not a Combination Product

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

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; Type 0: Not a Combination Product

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

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; Type 0: Not a Combination Product

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; Type 1: Convenience Kit of Co-Package

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. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-8977)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-8977)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Laboratories Inc.		001535103	manufacture(51531-8977)

Establishment
Name	Address	ID/FEI	Business Operations
Komplete Group Inc.		858820962	pack(51531-8977)