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Proactiv

Guthy-Renker LLC

Proactiv Solution Gentle Formula Clarifying Night Lotion


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Salicylic Acid 1%

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

When using this product

  • using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if skin irritation occurs.

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.

Inactive Ingredients

water (aqua), ethylhexyl palmitate, cetearyl alcohol, PPG-12/SMDI copolymer, cyclopentasiloxane, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalane, dicetyl phosphate, ceteth-10 phosphate, chamomilla recutita (matricaria) extract, aleurites moluccana seed oil, retinol, sodium ascorbate, tocopherol, retinyl palmitate, ascorbic acid, PEG-150, PEG-75, PEG-8 cetyl dimethicone, panthenol, sodium hyaluronate, hexylene glycol, caprylic/capric triglyceride, propylene glycol, dimethicone, polysorbate 60, glyceryl stearate, PEG-100 stearate, sodium hydroxide, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 30 mL Carton

Rodan & Fields

p roactiv®
SOLUTION

Gentle Formula

Clarifying
Night Lotion

P.M. 3

non-comedogenic

salicylic acid acne treatment

1 FL. OZ. 30 mL

Proactiv

Proactiv

SALICYLIC ACID LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11410-305
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Salicylic Acid SALICYLIC ACID 1 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 TUBE
2 NDC:11410-305-29 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2008-03-01


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Be sure to consult your doctor before taking any medication!
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