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Proactiv Solution

Guthy-Renker LLC

Proactiv Solution Repairing Treatment


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 the 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

  • cleanse the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer 1 to 3 times daily.
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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, use a sunscreen.

Proactiv Solution 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), ethoxydiglycol, cyclotetrasiloxane, cyclopentasiloxane, cetearyl alcohol, propylene glycol, dimethicone, glyceryl stearate, PEG-100 stearate, panthenol, allantoin, xanthan gum, ceteareth-20, carbomer, triethanolamine, diazolidinyl urea, methylparaben, propylparaben, fragrance (parfum)

Dist. By Guthy-Renker®
PO Box 14383 • Palm Desert, CA 92255-4383

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

Rodan & Fields
proactiv®

SOLUTION

3
REPAIRING
TREATMENT

benzoyl peroxide acne treatment

1 FL. OZ. 30 mL

Proactiv Solution

Proactiv Solution

Benzoyl Peroxide GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11410-906
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 2.5 mL

Inactive Ingredients

Ingredient Name Strength
water
DIETHYLENE GLYCOL MONOETHYL ETHER
CYCLOMETHICONE 5
propylene glycol
CETOSTEARYL ALCOHOL
DIMETHICONE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
PANTHENOL
ALLANTOIN
XANTHAN GUM
POLYOXYL 20 CETOSTEARYL ETHER
CARBOMER HOMOPOLYMER TYPE C
TROLAMINE
DIAZOLIDINYL UREA
METHYLPARABEN
PROPYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11410-906-10 30 in 1 BOTTLE, PLASTIC
2 NDC:11410-906-20 60 in 1 BOTTLE, PLASTIC
3 NDC:11410-906-89 89 in 1 BOTTLE, PLASTIC
4 NDC:11410-906-40 120 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2011-11-01


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Be sure to consult your doctor before taking any medication!
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