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Proactiv

Guthy-Renker LLC

Proactiv Solution Pore Cleansing System


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts for Pore Cleansing Solution

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment Solution

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 face and pat dry
  • remove clear backing sheet from the strip
  • apply several drops of Pore Cleansing Solution to the target area
  • avoid using strip near eye area
  • apply the shiny smooth side of the strip to wet area
  • gently press down to smooth out air bubbles
  • for best results, allow to dry 10 – 15 minutes
  • the strip will feel stiff when ready to be removed
  • slowly and carefully peel off strip from the edge
  • rinse any residue with warm water
  • If going outside, use a sunscreen.

Inactive Ingredients

ethoxydiglycol, alcohol denat., arnica Montana flower extract, camellia oleifera leaf extract, glycyrrhiza glabra (licorice) root extract, butylenes glycol, propylene glycol, water (aqua), diazolidinyl urea, methylparaben, propylparaben

Ingredients for Pore Strips

polyacrylic acid, silica, titanium dioxide, alcohol, polyethylene glycol monolaurate, l-menthol, menthe piperita (peppermint) oil, propylparaben, methylparaben, water (aqua)

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

Rodan & Fields

p roactiv ®
SOLUTION

Pore Cleansing
Solution

salicylic acid
acne treatment

STEP 1

0.5 FL. OZ. 15 mL

Proactiv

PRINCIPAL DISPLAY PANEL - 15 mL Carton

Rodan & Fields

p roactiv ®
SOLUTION

Pore Cleansing
System

salicylic acid
acne treatment

(10) Pore Strips and
(1) Pore Cleansing Solution 0.5 FL. OZ. 15 mL

Proactiv

Proactiv

SALICYLIC ACID SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11410-407
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Salicylic Acid SALICYLIC ACID 5 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11410-407-05 15 in 1 BOTTLE
2 NDC:11410-407-05 15 in 1 BOTTLE
3 NDC:11410-407-33 3 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2005-02-01


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