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Proactiv

Guthy-Renker LLC

Proactiv Solution Renewing Cleanser


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

Do not use this medication if you

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

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.

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.

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

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.

Proactiv 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

Proactiv

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

Proactiv

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Rodan & Fields

proactiv ®
SOLUTION

1
RENEWING
CLEANSER

benzoyl peroxide acne treatment

6 FL. OZ. 177 mL

Proactiv

Proactiv

Benzoyl Peroxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11410-927
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 0.025 g

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11410-927-40 120 in 1 BOTTLE, PLASTIC
2 NDC:11410-927-40 120 in 1 BOTTLE, PLASTIC
3 NDC:11410-927-20 60 in 1 BOTTLE, PLASTIC
4 NDC:11410-927-71 177 in 1 BOTTLE, PLASTIC
5 NDC:11410-927-71 177 in 1 BOTTLE, PLASTIC
6 NDC:11410-927-70 180 in 1 BOTTLE, PLASTIC
7 NDC:11410-927-70 180 in 1 BOTTLE, PLASTIC
8 NDC:11410-927-10 30 in 1 BOTTLE, PLASTIC
9 NDC:11410-927-80 240 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2010-08-01


Proactiv

Benzoyl Peroxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11410-923
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 0.025 g

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11410-923-10 30 in 1 BOTTLE, PLASTIC
2 NDC:11410-923-20 60 in 1 BOTTLE, PLASTIC
3 NDC:11410-923-40 120 in 1 BOTTLE, PLASTIC
4 NDC:11410-923-70 180 in 1 BOTTLE, PLASTIC
5 NDC:11410-923-71 177 in 1 BOTTLE, PLASTIC
6 NDC:11410-923-80 240 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2010-01-01


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Be sure to consult your doctor before taking any medication!
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