Proactiv Solution Renewing Cleanser

Proactiv by

Drug Labeling and Warnings

Proactiv by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV  RENEWING CLEANSER- benzoyl peroxide cream 
THE PROACTIV COMPANY LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Proactiv Solution Renewing Cleanser

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use this medication if you

• have very sensitive skin.
• are sensitive to Benzoyl Peroxide.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product.

OTC - WHEN USING SECTION

When using this product

• avoid unnecessary sun exposure and use a sunscreen.
• avoid contact with eyes, lips and mouth.
• 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation becomes severe.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Use morning and night.
• Apply a dime-sized amount to damp skin and gently massage for 1 to 2 minutes.
• Rinse thoroughly with warm water.
• Pat dry.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• If going outside, use a sunscreen.

Other information

• sensitivity test: apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.
• avoid contact with hair and dyed fabrics, which may be bleached by this product.

Inactive Ingredients

water (aqua), magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, sorbitol, dimethyl isosorbide, disodium PEG-12 dimethicone sulfosuccinate, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, polyethylene, cetyl esters, anthemis nobilis flower extract, sodium hyaluronate, sodium PCA, xanthan gum, tridecyl trimellitate, propylene glycol, Imidazolidinyl urea, methylparaben, propylparaben, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

Rodan & Fields

proactiv®
SOLUTION

1
RENEWING
CLEANSER

COMBINATION
THERAPY®

benzoyl peroxide acne treatment

1 FL. OZ. 30 mL

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

Rodan & Fields

proactiv®
SOLUTION

1
Renewing
Cleanser

Combination Therapy®

benzoyl peroxide acne treatment

2 FL. OZ. 60 mL

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Rodan & Fields

proactiv®
SOLUTION

1
RENEWING
CLEANSER

benzoyl peroxide acne treatment

6 FL. OZ. 177 mL

PROACTIV   RENEWING CLEANSER
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-927
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	0.025 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-927-40	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2010	01/01/2019
2	NDC: 11410-927-42	1 in 1 BOX	08/01/2010	01/01/2019
2	NDC: 11410-927-40	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 11410-927-20	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2010	01/01/2019
4	NDC: 11410-927-71	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2010	01/01/2019
5	NDC: 11410-927-73	1 in 1 BOX	08/01/2010	01/01/2019
5	NDC: 11410-927-71	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC: 11410-927-69	1 in 1 BOX	08/01/2010	01/01/2018
6	NDC: 11410-927-70	180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7	NDC: 11410-927-70	180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2010	01/01/2019
8	NDC: 11410-927-10	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2010	01/01/2019
9	NDC: 11410-927-80	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2010	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	08/01/2010	01/01/2019

PROACTIV   RENEWING CLEANSER
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-923
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	0.025 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-923-10	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2010	01/01/2019
2	NDC: 11410-923-20	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2010	01/01/2019
3	NDC: 11410-923-40	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2010	01/01/2019
4	NDC: 11410-923-70	180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2010	01/01/2018
5	NDC: 11410-923-71	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2010	01/01/2019
6	NDC: 11410-923-80	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2010	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/01/2010	01/01/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020

Document Id: fb33975c-4c9d-4382-8a6e-0eeaaa5a8e7a

34390-5

Set id: 6dae5e77-361c-423b-b4e7-ff9fde42be2c

Version: 3

Effective Time: 20200115

 

THE PROACTIV COMPANY LLC