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Proactiv Gentle Formula Clarifying Cleanser

Medically reviewed on December 5, 2017

Dosage form: cream
Ingredients: Salicylic Acid 0.02g in 1000mL
Labeler: THE PROACTIV COMPANY LLC
NDC Code: 11410-501

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.

proactiv® Gentle Formula Clarifying Cleanser

Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

When using this product

  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.
  • avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated below.
  • apply a small amount to dampened skin.
  • cover the entire affected area with a thin layer and rinse thoroughly one to three times daily.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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, Cocamidopropyl Betaine, Distearyl Phthalic Acid Amide, Polyethylene, Cetyl Alcohol, Stearyl Alcohol, PEG-120 Methyl Glucose Dioleate, Ammonium Laureth Sulfate, Sodium Chloride, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Microcrystalline Wax, Butylene Glycol, Disodium EDTA, Sodium Hydroxide, Menthol, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, Fragrance, Ferric Ferrocyanide, Blue 1

Questions or comments?
Within US 1-800-950-4695

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
proactiv.com ‚óŹ Within US 1-800-950-4695
Made in the USA of Foreign and Domestic Components
Proctiv is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 120 mL Carton

proactiv®             

Gentle Formula

clarifying
cleanser

1

salicylic acid acne medication

4 FL. OZ. 120 mL

PROACTIV GENTLE FORMULA CLARIFYING CLEANSER 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-501
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid0.02 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Cocamidopropyl Betaine 
Distearyl Phthalamic Acid 
High Density Polyethylene 
Cetyl Alcohol 
Stearyl Alcohol 
Peg-120 Methyl Glucose Dioleate 
Ammonium Laureth-5 Sulfate 
Sodium Chloride 
Aloe Vera Leaf 
Green Tea Leaf 
Microcrystalline Wax 
Butylene Glycol 
Edetate Disodium 
Sodium Hydroxide 
Menthol 
Phenoxyethanol 
Methylparaben 
Ethylparaben 
Butylparaben 
Propylparaben 
Isobutylparaben 
Ferric Ferrocyanide 
Fd&c Blue No. 1 
Packaging
#Item CodePackage Description
1NDC:11410-501-401 BOTTLE, PLASTIC in 1 CARTON
1120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2003
Labeler - THE PROACTIV COMPANY LLC (080216357)
Establishment
NameAddressID/FEIOperations
VEE PAK, LLC874763303manufacture(11410-501)

 
THE PROACTIV COMPANY LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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