Proactiv Solution Renewing Cleanser

Proactiv Renewing Cleanser by

Drug Labeling and Warnings

Proactiv Renewing Cleanser 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 - 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. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product

• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
• keep away from lips and mouth.
• avoid unnecessary sun exposure and use a sunscreen.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation occurs.

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

• This product may bleach hair or dyed fabrics.
• Store at room temperature. Avoid storing at extreme temperatures (below 40°F and above 100°F).

Inactive Ingredients

water (aqua), magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, disodium PEG-12 dimethicone sulfosuccinate, sorbitol, dimethyl isosorbide, 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 Label

Rodan & Fields

proactiv®
SOLUTION

Renewing
Cleanser

STEP 1

benzoyl peroxide acne treatment

1 FL. OZ. 30 mL

PROACTIV RENEWING CLEANSER 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-409
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	0.25 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: 11410-409-40	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2009	01/01/2019
2	NDC: 11410-409-20	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2009	01/01/2019
3	NDC: 11410-409-10	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2009	01/01/2019
4	NDC: 11410-409-70	180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2009	01/01/2019
5	NDC: 11410-409-42	1 in 1 CARTON	01/01/2009	01/01/2019
5		120 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 final	part333D	01/01/2009	01/01/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020

Document Id: bc693ff4-48bf-49a6-87aa-bf87cd0907d8

34390-5

Set id: 47e5baa5-9578-4943-b05b-f75ca252b09c

Version: 2

Effective Time: 20200109

 

THE PROACTIV COMPANY LLC