FDA.reportPublic FDA data

Proactiv Emergency Blemish Relief

Manufacturer
Alchemee, LLC | Apex International Mfg LLC | Vee Pak Inc.
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:31:46

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. 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 t...

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 

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

water, cyclopentasiloxane, ethoxydiglycol, steareth-2, methylpropanediol, steareth-21, polyquaternium-37, propylene glycol dicaprylate/dicaprate, phenoxyethanol, caprylyl glycol, fragrance, panthenol, allantoin, ethylhexylglycerin, PPG-1 trideceth-6

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 trademark of
Taro Pharmaceutical U.S.A., Inc.

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

unit carton image
unit carton image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308693benzoyl peroxide 5 % Topical CreamPSN8
308693benzoyl peroxide 50 MG/ML Topical CreamSCD8
308693benzoyl peroxide 5 % Topical CreamSY8

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
11410-012-09Proactiv Emergency Blemish Relief9.45 g in 1 TUBECREAM9.458
11410-012-09Proactiv Emergency Blemish Relief1 in 1 BOXCREAM18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GM1
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GM1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BA1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW41
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02B1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
METHYLPROPANEDIOLINACTIVE INGREDIENTN8F53B3R4R1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
POLYQUATERNIUM-37 (3000 MPA.S)INACTIVE INGREDIENTHU373G0YSU1
PPG-1 TRIDECETH-6INACTIVE INGREDIENT1K7417JX6Q1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATEINACTIVE INGREDIENTO4446S9CRA1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
STEARETH-2INACTIVE INGREDIENTV56DFE46J51
STEARETH-21INACTIVE INGREDIENT53J3F32P581
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-01211410-012-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
CYCLOMETHICONE 50THT5PCI0RIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
STEARETH-2V56DFE46J5IACT
STEARETH-2153J3F32P58IACT
POLYQUATERNIUM-37 (3000 MPA.S)HU373G0YSUIACT
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATEO4446S9CRAIACT
PPG-1 TRIDECETH-61K7417JX6QIACT
PANTHENOLWV9CM0O67ZIACT
ALLANTOIN344S277G0ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARETH-21STEARETH-2153J3F32P58CREAM / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BCREAM / TOPICAL1290 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
STEARETH-21STEARETH-2153J3F32P58CREAM / TOPICAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BCREAM / TOPICAL1290 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii+route
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
STEARETH-2STEARETH-2V56DFE46J5CREAM / TOPICAL643 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
STEARETH-2STEARETH-2V56DFE46J5CREAM / TOPICAL643 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Proactiv Emergency Blemish ReliefBENZOYL PEROXIDEAlchemee, LLC72bb45ca-3f68-47be-928e-755cc66419d92026-01-07WarningsExact identifier
ndc (package): 11410-012-09
ndc (product): 11410-012
ndc11 (package): 11410001209
spl id: 47d2870b-99be-9987-e063-6294a90af97c
spl set id: 72bb45ca-3f68-47be-928e-755cc66419d9

Reported adverse events (FAERS/openFDA)#

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