PROACTIV  PORE CLEANSING SYSTEM- salicylic acid solution 
THE PROACTIV COMPANY LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Proactiv Solution Pore Cleansing System

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

proactiv®
SOLUTION

Pore Cleansing
Solution

salicylic acid
acne treatment

STEP 1

0.5 FL. OZ. 15 mL

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 15 mL Carton

Rodan & Fields

proactiv®
SOLUTION

Pore Cleansing
System

salicylic acid
acne treatment

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

Principal Display Panel - 15 mL Carton
PROACTIV   PORE CLEANSING SYSTEM
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-407
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-407-0515 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/200512/31/2019
2NDC:11410-407-451 in 1 BOX02/01/200512/31/2019
2NDC:11410-407-0515 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:11410-407-333 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/200512/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D02/01/200512/31/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 8/2010
 
THE PROACTIV COMPANY LLC