FDA.reportPublic FDA data

Proactiv Repairing Treatment

Manufacturer
The Proactiv Company, LLC
Effective date
2017-03-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:17:11

Label at a glance#

ProductProactiv Repairing Treatment
Active ingredientBenzoyl Peroxide
Label structure9 sections

Dosage and administration

Sensitivity Test for a New User: Apply 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 to three times daily. because excessive drying of the skin may occur, start with one application daily, then gradually increase to two o...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 2.5%

Purpose

OTC - PURPOSE SECTION

Acne treatment gel

Use

INDICATIONS & USAGE SECTION

for the management of acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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 unnecessary sun exposure and use a sunscreen.
  • avoid contact with the eyes, lips, and mouth.
  • avoid contact with hair and dyed fabrics, which may be bleached by this product.
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

OTC - DO NOT USE SECTION

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • irritation becomes severe.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Sensitivity Test for a New User: Apply 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 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 use to once a day or every other day.
  • if going outside, apply sunscreen. If irritation or sensitivity develops, stop use and ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, ethoxydiglycol, cyclotetrasiloxane, cyclopentasiloxane, propylene glycol, cetearyl alcohol, dimethicone, glyceryl stearate, PEG-100 stearate, panthenol, allantoin, xanthan gum, ceteareth-20, carbomer, sodium hydroxide, diazolidinyl urea, methylparaben, propylparaben, fragrance

SPL UNCLASSIFIED SECTION

Distributed by The Proactiv Company LLC • 100 N Sepulveda Blvd., El Segundo CA 90245

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv®

REPAIR

3

REPAIRING
TREATMENT

4 FL. OZ. 120 mL

benzoyl peroxide acne medication

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-04011410-040-10, 11410-040-20, 11410-040-32, 11410-040-40

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzoyl PeroxideW9WZN9A0GMACTIB
WATER059QF0KO0RIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
CYCLOMETHICONE 4CZ227117JEIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PANTHENOLWV9CM0O67ZIACT
ALLANTOIN344S277G0ZIACT
XANTHAN GUMTTV12P4NEEIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
SODIUM HYDROXIDE55X04QC32IIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proactiv Repairing TreatmentBENZOYL PEROXIDEAlchemee, LLC9bbf6db0-ff80-44d2-b81b-40080ca46b922026-01-07WarningsExact identifier
ndc (product): 11410-040
24aca484-b620-4ea0-a23b-aa69855558b1fc67798f-9027-4704-a9fb-c2c55958de052017-03-13WarningsExact identifier
spl id: 24aca484-b620-4ea0-a23b-aa69855558b1
spl set id: fc67798f-9027-4704-a9fb-c2c55958de05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.