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Proactiv

Guthy-Renker LLC

Proactiv Solution Extra Strength Formula Lotion


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Benzoyl Peroxide 7%

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

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

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 medication.
  • 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 Other information

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

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL - 2 FL. OZ. 60 mL Bottle Carton

Rodan & Fields

proactiv ®
SOLUTION

EXTRA STRENGTH
FORMULA

lotion

3

benzoyl peroxide acne treatment

2 FL. OZ. 60 mL

Proactiv

Proactiv

BENZOYL PEROXIDE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11410-304
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 7 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11410-304-10 30 in 1 BOTTLE
2 60 in 1 BOTTLE
3 NDC:11410-304-23 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2003-12-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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