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Proactiv Gentle Formula Clearifying Night

Medically reviewed on July 16, 2018

Dosage form: lotion
Ingredients: SALICYLIC ACID 1mg in 100mL
Labeler: THE PROACTIV COMPANY LLC
NDC Code: 11410-305

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 Solution Gentle Formula Clarifying Night Lotion

Drug Facts

Active Ingredient

Salicylic Acid 1.0%

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.
  • cleanse the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer one or 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, Ethylhexyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, PPG-12/SMDI Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Hexylene Glycol, Dicetyl Phosphate, Ceteth-10 Phosphate, Chamomilla Recutita (Matricaria) Flower Extract,  Aleurites Moluccana Seed Oil, Retinol, Sodium Ascorbate, Tocopherol, Retinyl Palmitate, Ascorbic Acid, PEG-180, PEG-75, PEG-8 Cetyl Dimethicone, Panthenol, Sodium Hyaluronate, Caprylic/Capric Triglyceride, Propylene Glycol, Dimethicone, Polysorbate 60, Glyceryl Stearate, PEG-100 Stearate, Sodium Hydroxide, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, fragrance

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
Made in the USA of Foreign and Domestic Components
Proactiv is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 30 mL Carton

proactiv®

Gentle Formula

Clarifying
Night Lotion

P.M. 3

salicylic acid acne medication

1 FL. OZ. 30 mL

PROACTIV   GENTLE FORMULA CLEARIFYING NIGHT
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-305
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Ethylhexyl Palmitate 
Cetostearyl Alcohol 
Cyclomethicone 5 
Ppg-12/smdi Copolymer 
Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) 
Squalane 
Hexylene Glycol 
Dihexadecyl Phosphate 
Ceteth-10 Phosphate 
Matricaria Recutita 
Kukui Nut Oil 
Retinol 
Sodium Ascorbate 
Tocopherol 
Vitamin A Palmitate 
Ascorbic Acid 
Polyethylene Glycol 8000 
Polyethylene Glycol 3350 
Panthenol 
Hyaluronate Sodium 
Medium-chain Triglycerides 
Propylene Glycol 
Dimethicone 
Polysorbate 60 
Glyceryl Monostearate 
Phenoxyethanol 
Methylparaben 
Ethylparaben 
Butylparaben 
Propylparaben 
Isobutylparaben 
Peg-8 Dimethicone 
Packaging
#Item CodePackage Description
1NDC:11410-305-291 TUBE in 1 BOX
130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D03/01/2008
Labeler - THE PROACTIV COMPANY LLC (080216357)
Establishment
NameAddressID/FEIOperations
VEE PAK, LLC874763303manufacture(11410-305)

 
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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