PROACTIV RENEWING CLEANSER- benzoyl peroxide gel

Proactiv Renewing Cleanser by

Drug Labeling and Warnings

Proactiv Renewing Cleanser by is a Otc medication manufactured, distributed, or labeled by The Proactiv Company, LLC, VEE PAK, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzoyl peroxide 2.5%

Purpose

Acne treatment gel

Use

for the management of acne

Warnings

For external use only

When using this product

• do not use this product more than three times per day.
• skin irritation and dryness are 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 use if 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.

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.
• apply a small amount to dampened skin.
• 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.
• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

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, anthemis nobilis flower extract, tridecyl trimellitate, trisodium sulfosuccinate, PEG-12 dimethicone, sodium sulfate, sodium hyaluronate, propylene glycol, sodium PCA, xanthan gum, phenoxyethanol, imidazolidinyl urea, methylparaben, propylparaben, fragrance

Questions or comments?

Within US 1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245 ● proactiv.com
Made in the USA of foreign and domestic components

Proacitv is a trademark of The Proactiv Company Sàrl

PRINCIPAL DISPLAY PANEL - 60 mL Carton

proactiv®                 

CLEANSE

1

RENEWING
CLEANSER

 2 FL. OZ. 60 mL

benzoyl peroxide acne medication

PRINCIPAL DISPLAY PANEL - 120 mL CARTON

proactiv®

CLEANSE
1
RENEWING
CLEANSER
4 FL. OZ. 120 mL

benzoyl peroxide acne medication

PRINCIPAL DISPLAY PANEL - 120 mL Label

proactiv®

CLEANSE
1
RENEWING
CLEANSER
4 FL. OZ. 120 mL

benzoyl peroxide acne medication

INGREDIENTS AND APPEARANCE

PROACTIV RENEWING CLEANSER 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	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)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Peg-100 Stearate (UNII: YD01N1999R)
Sorbitol (UNII: 506T60A25R)
Dimethyl Isosorbide (UNII: SA6A6V432S)
Tridecyl Stearate (UNII: A8OE252M6L)
Neopentyl Glycol Dicaprylate/dicaprate (UNII: VLW429K27K)
Paraffin (UNII: I9O0E3H2ZE)
Cetyl Esters Wax (UNII: D072FFP9GU)
Chamaemelum Nobile Flower (UNII: O2T154T6OG)
Tridecyl Trimellitate (UNII: FY36J270ES)
Trisodium Sulfosuccinate (UNII: 085WB9L09N)
Peg-12 Dimethicone (300 Cst) (UNII: ZEL54N6W95)
Sodium Sulfate (UNII: 0YPR65R21J)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Xanthan Gum (UNII: TTV12P4NEE)
Phenoxyethanol (UNII: HIE492ZZ3T)
Imidurea (UNII: M629807ATL)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Disodium Laureth-12 Sulfosuccinate (UNII: F8I0R9Q3ZX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-005-00	1 in 1 CARTON	03/07/2017
1		60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 11410-005-05	1 in 1 CARTON	03/07/2017
2		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 11410-005-40	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2011
4	NDC: 11410-005-20	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/23/2019
5	NDC: 11410-005-10	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2011
6	NDC: 11410-005-70	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2011
7	NDC: 11410-005-80	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2011
8	NDC: 11410-005-01	1 in 1 CARTON	03/07/2017
8		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 11410-005-75	1 in 1 CARTON	01/01/2020
9		177 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	10/21/2011

Labeler - The Proactiv Company, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-005)