PROACTIV SOLUTION KIT- solutions kit kit

Proactiv Solution Kit by

Drug Labeling and Warnings

Proactiv Solution 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]

Renewing Cleanser - Drug Facts

Drug Facts

Repairing Treatment - Drug Facts

Drug Facts

Renewing Cleanser- Active ingredient

Benzoyl peroxide 2.5%

Repairing Treatment - Active Ingredient

Benzoyl peroxide 2.5%

Renewing Cleanser - Purpose

Acne treatment

Repairing Treatment - Purpose

​Acne treatment

Renewing Cleanser - Use

for the management of acne

Repairing Treatment - Use

for the management of acne

Renewing Cleanser - Warnings

For external use only

Renewing 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.
• 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.

Do not useif you

• have very sensitive skin
• are sensitive to benzoyl peroxide

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.

Repairing Treatment - Warnings

For external use only

Renewing 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.
avoid unnecessary sun exposure and use a sunscreen.
avoid contact with 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.

Repairing Treatment - 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 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.

Renewing Cleanser - Do not use if you

have very sensitive skin.

Repairing Treatment - Do not use if you

have very sensitive skin.

are sensitive to benzoyl peroxide.

Renewing Cleanser - Stop use and ask a doctor if

Irritation becomes Severe

Repairing Treatment - Stop use and ask a doctor if

irritation becomes severe.

Renewing Cleanser - Keep out of reach of children

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

Repairing Treatment - Keep out of reach of children

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

Repairing Treatment - Keep out of reach of children

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

Renewing 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 thoroughlyone 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.

Repairing Treatment - 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.
clear 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.

Repairing Treatment - other information

Store at 20oC – 25oC (68o – 77oF).

Renewing Cleanser - Other information

Store at 20oC – 25oC (68o – 77oF).

Repairing Treatment - Other Informations

Store at 20oC – 25oC (68o – 77oF).

Renewing Cleanser - Inactive ingredients

water, magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, sorbitol, dimethyl isosorbide, disodium PEG-12 dimethicone sulfosuccinate, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, paraffin, cetyl esters, tridecyl trimellitate, trisodium sulfosuccinate, PEG-12 dimethicone, xanthan gum, imidazolidinyl urea, fragrance, methylparaben, sodium sulfate, propylparaben, sodium PCA, propylene glycol, anthemis nobilis flower extract, phenoxyethanol, sodium hyaluronate

Repairing Treatment - Inactive Ingredient

water, ethoxydiglycol, cyclopentasiloxane, propylene glycol, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, ceteareth-20, diazolidinyl urea, carbomer, fragrance, methylparaben, xanthan gum, panthenol, allantoin, sodium hydroxide, propylparaben.

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 Solution

3-step acne treatment system

Featuring micronized benzoyl peroxide

Step 1: Cleanse

Washes away debris & treats acne

Step 2: Tone

Refreshes & removes impurities

Step 3: Repair

Helps Kill acne-causing bacteria

Kits Contains: RENEWING CLEANSER 2 FL. OZ. (60 mL) Revitalizing Toner 2 FL. OZ. (60 mL) Repairing Treatment 1 FL. OZ. (30mL)

INGREDIENTS AND APPEARANCE

PROACTIV SOLUTION KIT 
solutions kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-215

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-215-30	1 in 1 BOX; Type 0: Not a Combination Product	05/08/2024
2	NDC: 11410-215-60	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 BOTTLE	60 mL  in 100
Part 2	1 BOTTLE	60 mL  in 100
Part 3	1 BOTTLE, PLASTIC	60 mL  in 100

Part 1 of 3

PROACTIV RENEWING CLEANSER 
benzoyl peroxide gel

Product Information
Item Code (Source)	NDC: 11410-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
TRIDECYL STEARATE (UNII: A8OE252M6L)
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PARAFFIN (UNII: I9O0E3H2ZE)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SORBITOL (UNII: 506T60A25R)
TRISODIUM SULFOSUCCINATE (UNII: 085WB9L09N)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PEG-100 STEARATE (UNII: YD01N1999R)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-005-20	60 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 Drug	M006	10/21/2011

Part 2 of 3

REVITALIZING TONER 
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	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	GLYCOLIC ACID (UNII: 0WT12SX38S)
INGR	CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	SULISOBENZONE (UNII: 1W6L629B4K)
INGR	DIRECT BLUE 1 (UNII: 8NN34MAQ6H)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	IMIDUREA (UNII: M629807ATL)
INGR	WATER (UNII: 059QF0KO0R)
INGR	WITCH HAZEL (UNII: 101I4J0U34)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
INGR	BASIC YELLOW 5 (UNII: 07BP340B4T)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 mL in 1 BOTTLE; 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 3

PROACTIV REPAIRING TREATMENT 
benzoyl peroxide gel

Product Information
Item Code (Source)	NDC: 11410-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-100 STEARATE (UNII: YD01N1999R)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ALLANTOIN (UNII: 344S277G0Z)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-040-15	60 mL in 1 BOTTLE, PLASTIC; 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	11/01/2011

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(11410-215)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-215)