FDA.reportPublic FDA data

Proactiv plus Pore Targeting Treatment

Manufacturer
Alchemee, LLC | Apex International Mfg LLC | VEE PAK, LLC
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:31:38

Label at a glance#

ProductProactiv plus Pore Targeting Treatment
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. clean 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 ...

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

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 is 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 useif you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if 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.
  • clean 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

carbomer, disodium EDTA, ethoxydiglycol, fragrance, glycerin, polysorbate 60, polysorbate 80, potassium hydroxide, prunus amygdalus dulcis (sweet almond) oil, sorbitan stearate, water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by Alchemee LLC
Santa Monica, CA 90401
Made in the USA of Foreign and
Domestic Components
Questions? 1-800-950-4695 • proactiv.com

Proactiv is a registered trademark of
Taro Pharmaceuticals U.S.A., Inc.

PRINCIPAL DISPLAY PANEL - 30 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv+

Pore
Targeting
Treatment

1 FL. OZ.  (30 mL)
benzoyl peroxide
acne treatment

unit carton image
unit carton image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308689benzoyl peroxide 2.5 % Topical GelPSN11
308689benzoyl peroxide 0.025 MG/MG Topical GelSCD11
308689benzoyl peroxide 2.5 % Topical GelSY11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11410-046-00Proactiv plus Pore Targeting Treatment1 in 1 BOXGEL111
11410-046-00Proactiv plus Pore Targeting Treatment30 mL in 1 BOTTLE, PUMPGEL3011
11410-046-05Proactiv plus Pore Targeting Treatment89 mL in 1 BOTTLE, PUMPGEL8911
11410-046-05Proactiv plus Pore Targeting Treatment1 in 1 BOXGEL111
11410-046-10Proactiv plus Pore Targeting Treatment1 in 1 CARTONGEL111
11410-046-10Proactiv plus Pore Targeting Treatment10 mL in 1 TUBEGEL1011
11410-046-15Proactiv plus Pore Targeting Treatment1 in 1 CARTONGEL111
11410-046-15Proactiv plus Pore Targeting Treatment89 mL in 1 TUBEGEL8911
11410-046-20Proactiv plus Pore Targeting Treatment30 mL in 1 TUBEGEL3011
11410-046-20Proactiv plus Pore Targeting Treatment1 in 1 CARTONGEL111
11410-046-25Proactiv plus Pore Targeting Treatment89 mL in 1 TUBEGEL8911

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-04611410-046-05, 11410-046-00, 11410-046-15, 11410-046-10, 11410-046-20, 11410-046-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
GLYCERINPDC6A3C0OXIACT
ALMOND OIL66YXD4DKO9IACT
POLYSORBATE 806OZP39ZG8HIACT
POLYSORBATE 60CAL22UVI4MIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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 plus Pore Targeting TreatmentBENZOYL PEROXIDEAlchemee, LLC12f2eeab-d258-4eb1-8fe2-784c51c2e4cc2026-01-07WarningsExact identifier
ndc (package): 11410-046-20
ndc (package): 11410-046-00
ndc (package): 11410-046-25
ndc (package): 11410-046-15
ndc (package): 11410-046-05
ndc (package): 11410-046-10
ndc (product): 11410-046
ndc11 (package): 11410004610
ndc11 (package): 11410004625
ndc11 (package): 11410004620
ndc11 (package): 11410004600
ndc11 (package): 11410004605
ndc11 (package): 11410004615
spl id: 47d282f1-f49e-6e59-e063-6294a90ad058
spl set id: 12f2eeab-d258-4eb1-8fe2-784c51c2e4cc
Proactiv Plus KitSOLUTIONS KITAlchemee, LLC1bbe19ff-0bc8-7b8b-e063-6394a90aa7f42026-01-07WarningsExact identifier
ndc (package): 11410-046-20
ndc11 (package): 11410004620

Reported adverse events (FAERS/openFDA)#

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