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 - 30 mL Bottle Label

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 - 60 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Rodan & Fields

proactiv®
SOLUTION

1
RENEWING
CLEANSER

benzoyl peroxide acne treatment

6 FL. OZ. 177 mL

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
PROACTIV   RENEWING CLEANSER
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-927
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide0.025 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-927-40120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/201001/01/2019
2NDC:11410-927-421 in 1 BOX08/01/201001/01/2019
2NDC:11410-927-40120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:11410-927-2060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/201001/01/2019
4NDC:11410-927-71177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/201001/01/2019
5NDC:11410-927-731 in 1 BOX08/01/201001/01/2019
5NDC:11410-927-71177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:11410-927-691 in 1 BOX08/01/201001/01/2018
6NDC:11410-927-70180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7NDC:11410-927-70180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/201001/01/2019
8NDC:11410-927-1030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/201001/01/2019
9NDC:11410-927-80240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/201001/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D08/01/201001/01/2019
PROACTIV   RENEWING CLEANSER
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-923
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide0.025 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-923-1030 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/201001/01/2019
2NDC:11410-923-2060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/201001/01/2019
3NDC:11410-923-40120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/201001/01/2019
4NDC:11410-923-70180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/201001/01/2018
5NDC:11410-923-71177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/201001/01/2019
6NDC:11410-923-80240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/201001/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/01/201001/01/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020
Document Id: fb33975c-4c9d-4382-8a6e-0eeaaa5a8e7a
Set id: 6dae5e77-361c-423b-b4e7-ff9fde42be2c
Version: 3
Effective Time: 20200115
 
THE PROACTIV COMPANY LLC