FDA.reportPublic FDA data

Proactiv Emergency Blemish Relief

Manufacturer
The Proactiv Company, LLC | Vee Pak Inc. | KIK Custom Product - Rexdale Plant
Effective date
2017-04-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:23:41

Label at a glance#

ProductProactiv Emergency Blemish Relief
Active ingredientBenzoyl Peroxide
Label structure10 sections

Dosage and administration

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 to three times daily. because excessive drying of the skin may occur, start with one application daily, then gradually increase ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 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

  • do not use this product more than three times per day.
  • 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 - STOP USE 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 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 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.
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, ethoxydiglycol, cyclopentasiloxane, methylpropanediol, steareth-2, cyclohexasiloxane, steareth-21, polyquaternium-37, propylene glycol dicaprylate/dicaprate, propylene glycol, PPG-1 trideceth-6, panthenol, allantoin, diazolidinyl urea, methylparaben, propylparaben, fragrance

Questions or comments?

OTC - QUESTIONS SECTION

Within US 1-800-950-4695

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 9.45 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv®

EMERGENCY
BLEMISH
RELIEF

0.33 OZ. 9.45 g

benzoyl peroxide
acne medication

PRINCIPAL DISPLAY PANEL - 9.45 g Tube Box
PRINCIPAL DISPLAY PANEL - 9.45 g Tube Box

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-04211410-042-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzoyl PeroxideW9WZN9A0GMACTIB
WATER059QF0KO0RIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
CYCLOMETHICONE 50THT5PCI0RIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
STEARETH-2V56DFE46J5IACT
CYCLOMETHICONE 6XHK3U310BAIACT
STEARETH-2153J3F32P58IACT
POLYQUATERNIUM-37 (3000 MPA.S)HU373G0YSUIACT
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATEO4446S9CRAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PPG-1 TRIDECETH-61K7417JX6QIACT
PANTHENOLWV9CM0O67ZIACT
ALLANTOIN344S277G0ZIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2e8d8c5d-5f40-4b3c-8c29-6aeca5ac5177f7c8bcd5-db97-42dc-b444-65da0437171c2017-04-03WarningsExact identifier
spl id: 2e8d8c5d-5f40-4b3c-8c29-6aeca5ac5177
spl set id: f7c8bcd5-db97-42dc-b444-65da0437171c

Reported adverse events (FAERS/openFDA)#

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