PROACTIV CLEAN KIT- clean kit kit

Proactiv Clean Kit by

Drug Labeling and Warnings

Proactiv Clean Kit by is a Otc medication manufactured, distributed, or labeled by Alchemee, LLC, kdc/one Chatsworth, Inc., VEE PAK, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Mineral Acne Cleanser - Drug Facts

Drug Facts

Acne Clearing Hydrator - Drug Facts

Drug Facts

Mineral Acne Cleanser - Active ingredient

Sulfur 3%

Acne Clearing Hydrator - Active Ingredient

Salicylic acid 2%

Mineral Acne Cleanser - Purpose

Acne treatment

Acne Clearing Hydrator - Purpose

​Acne treatment

Mineral Acne Cleanser - Use

for the management of acne

Acne Clearing Hydrator - Use

for the management of acne

Mineral Acne Cleanser - Warnings

For external use only

Acne Clearing Hydrator - Warnings

For external use only

Mineral Acne Cleanser - 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.
• apply only to areas with acne
• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Acne Clearing Hydrator - 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 eyes.

if contact occurs, rinse eyes thoroughly with water.

Mineral Acne Cleanser - Do not use if you

on

• broken skin
• large areas of the skin

Mineral Acne Cleanser - Keep out of reach of children

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

Acne Clearing Hydrator - Keep out of reach of children

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

Mineral Acne Cleanser - Directions

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs follow the directions stated below.

• cover the entire affected area with a thin layer

and 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.

Acne Clearing Hydrator - Directions

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. clean 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 a if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Mineral Acne Cleanser - Other information

Store at 20oC – 25oC (68o – 77oF).

Acne Clearing Hydrator - Other Informations

Store at 20oC – 25oC (68o – 77oF).

Mineral Acne Cleanser - Inactive ingredients

Water, Sodium Cocoyl Isethionate, Coco-Glucoside, Acrylates Copolymer, Coconut Acid, Coconut Alcohol, Glycereth-18 Ethylhexanoate, Glycereth-18, Behenyl Alcohol, Titanium Dioxide (CI 77891), Phenoxyethanol, Sodium Isethionate, Sodium Hydroxide, Arachidyl Alcohol, Stearyl Alcohol, Xanthan Gum, Ethylhexylglycerin, Glycerin, Tetrasodium Glutamate Diacetate, Chamomilla Recutita (Matricaria) Flower Extract

Acne Clearing Hydrator - Inactive Ingredient

Water, Glycerin, Glyceryl Stearate SE, Propanediol, Cetyl Phosphate, Cetyl Alcohol, Stearic Acid, Dicaprylyl Carbonate, Undecane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Pentylene Glycol, Cetearyl Alcohol, Tridecane, Bakuchiol, Caprylyl Glycol, Xanthan Gum, Ethylhexylglycerin, Tocopheryl Acetate, Sodium Hyaluronate, Phenoxyethanol, Tocopherol

Questions or comments?  

1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by Alchemee LLC
Santa Monica, CA 90401
Made in the USA of Foreign
and Domestic Components
Questions? 1-800-950-4695 proactiv.com

Proactiv is a registered trademark
of Taro Pharmaceuticals U.S.A., Inc.

PRINCIPAL DISPLAY PANEL - Proactiv Solution Kit

proactiv®

Proactiv Clean

3-step Mild Acne-Fighting

Treatment routine

Featuring sulfur, azelaic acid, and salicylic acid

Step 1: Cleanse

Gently Washes away excess dirt and oil with mineral-derived sulfur

Step 2: Refine

Decongests pores and helps improve the look of uneven skin tone with azelaic acid

Step 3: Hydrate

Helps keep skin clear with acne-clearing salicylic acid

Kit Contains:
Mineral Acne Cleanser 2 FL. OZ. (60 mL) Azelaic Pore Perfector 1 FL. OZ. (30 mL)
Acne Clearing Hydrator 1 FL. OZ. (30 mL) Zits Happens Patches 15 count

INGREDIENTS AND APPEARANCE

PROACTIV CLEAN KIT 
clean kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-228

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-228-30	1 in 1 BOX; Type 0: Not a Combination Product	05/08/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	60 mL  in 100
Part 2	1 TUBE	30 mL  in 100
Part 3	1 TUBE	30 mL  in 100
Part 4	1 CELLO PACK	15   in 100

Part 1 of 4

PROACTIV CLEAN MINERAL ACNE CLEANSER 
sulfur cream

Product Information
Item Code (Source)	NDC: 11410-457
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y)
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
GLYCERETH-18 (UNII: SA5E43C17C)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
COCONUT ACID (UNII: 40U37V505D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
COCO GLUCOSIDE (UNII: ICS790225B)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
SODIUM ISETHIONATE (UNII: 3R36J71C17)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-457-15	60 mL 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 Drug	M006	08/15/2022

Part 2 of 4

PA CLEAN AZELAIC PORE PERFECTOR 
cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)] liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	LEVOMENOL (UNII: 24WE03BX2T)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
INGR	AZELAIC ACID (UNII: F2VW3D43YT)
INGR	GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER (300000 CP AT 2%) (UNII: MEA9KH24QG)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	BETASIZOFIRAN (UNII: 2X51AD1X3T)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	POLY-L-LYSINE (30000-70000 MW) (UNII: 0A1V8JTU2M)
INGR	WATER (UNII: 059QF0KO0R)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 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		05/08/2024

Part 3 of 4

PROACTIV CLEAN ACNE CLEARING HYDRATOR 
salicylic acid gel

Product Information
Item Code (Source)	NDC: 11410-458
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 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRIDECANE (UNII: A3LZF0L939)
BAKUCHIOL (UNII: OT12HJU3AR)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL PHOSPHATE (UNII: VT07D6X67O)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
UNDECANE (UNII: JV0QT00NUE)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
PENTYLENE GLYCOL (UNII: 50C1307PZG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-458-05	30 mL 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 Drug	M006	02/01/2023

Part 4 of 4

ZITS HAPPEN PATCHES 
cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)] patch

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	MADECASSIC ACID (UNII: M7O1N24J82)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	ASIATICOSIDE (UNII: PKO39VY215)
INGR	HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
INGR	STYRENE/ISOPRENE COPOLYMER (28:72; 210000 MW) (UNII: H58HX2GWJ5)
INGR	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
INGR	PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
INGR	ASIATIC ACID (UNII: 9PA5A687X5)
INGR	WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		15 in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		05/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	05/08/2024

Labeler - Alchemee, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
kdc/one Chatsworth, Inc.		118542196	manufacture(11410-228)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-228)