PROACTIV CLEAN BEGINNER BUNDLE- clean kit kit

Proactiv Clean Beginner Bundle by

Drug Labeling and Warnings

Proactiv Clean Beginner Bundle 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

Mineral Acne Cleanser - Active ingredient

Sulfur 3%

Mineral Acne Cleanser - Purpose

Acne treatment

Mineral Acne Cleanser - Use

for the management of acne

Mineral Acne Cleanser - 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

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.

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.

Mineral Acne Cleanser - Other information

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

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 Clean Beginner Breakouts Bundle

proactiv®

Proactiv Clean

Beginner

Breakouts Bundle

2-Piece Limited Ulta Exclusive

Formulated without parabens, phthalates,

cyclic silicones, and sulfates

Mineral Acne Cleanser 2 FL. OZ. (60 mL) Azelaic Pore Perfector 1 FL. OZ. (30 mL)

INGREDIENTS AND APPEARANCE

PROACTIV CLEAN BEGINNER BUNDLE 
clean kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-229

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-229-01	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 1 of 2

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 2

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 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(11410-229)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-229)