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Proactiv

Guthy-Renker LLC

Proactiv Solution Clear Zone Body Lotion


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Salicylic Acid 2.0%

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 one 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.

Inactive Ingredients

water (aqua), cyclopentasiloxane, dimethicone, PPG-12/SMDI copolymer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalane, glyceryl stearate, PEG-100 stearate, rosmarinus officinalis (rosemary) leaf extract, melaleuca alternifolia (tea tree) extract, chamomilla recutita (matricaria) flower extract, retinyl palmitate, linoleamidopropyl PG-dimonium chloride phosphate, glycerin, cetearyl alcohol, polysorbate 60, propylene glycol, hexylene glycol, sodium hydroxide, phenoxyethanol, chlorphenesin, methylparaben, benzoic acid, fragrance (parfum)

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

Rodan & Fields

proactiv ®
SOLUTION

CLEAR ZONE®
BODY LOTION

non-comedogenic
for face and body

salicylic acid acne treatment

8 FL. OZ. 240 mL

Proactiv

Proactiv

SALICYLIC ACID LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11410-301
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Salicylic Acid SALICYLIC ACID 2 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11410-301-20 60 in 1 BOTTLE
2 NDC:11410-301-40 120 in 1 BOTTLE
3 NDC:11410-301-80 240 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2004-01-01


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Be sure to consult your doctor before taking any medication!
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