Breakout Control

Manufacturer
Bioelements, Inc.
Effective date
2024-07-11
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:55:50

Label at a glance#

ProductBreakout Control Bioelements
Active ingredientBENZOYL PEROXIDE
Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Benzoyl Peroxide 5% Acne treatment

OTC - PURPOSE SECTION

Uses

For the treatment of acne

Helps prevent new acne blemishes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if:

irritation becomes severe

WARNINGS SECTION

Warnings

For external use only

When using this product

- Skin irritation and dryness is more likely to occur if you use antoher topical acne medication at the same time. If irritation occurs only use only one topical acne medication at a time.

- Avoid unnecessary sun exposure and use a sunscreen

- Avoid contact with 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.

- Do not use if you:

Have very sensitive skin

Are sensitive to benzoyl peroxide

DOSAGE & ADMINISTRATION SECTION

Directions

Cleanse the skin thoroughly before applying this product

cover the entire 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 INGREDIENT SECTION

Inactive ingredients

Water (Aqua,Eau), Pentylene Glycol, Hydroxyethyl Acrylates/Sodium Acryloyldimethyl Taurate Copolymer, Squalene, Polysorbate 60, Aloe Bardadensis (Aloe) Leaf Juice powder, Phytic Acid, Phyenoxyethanol, Potassium Sorbate, Disodium EDTA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bioelements

Breakout control

5% benzoyl peroxide acne treatment

invisibly spot treats to clear acne breakouts

29 mL/ 1 Fl. Oz.

BottleBottle

BoxBox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49825-129-022024-08-27C16284748780-11030e365-0014-111a-e063-dadaa90a10e2Breakout Control
49825-129-022024-01-30C16284748780-11030e365-0014-111a-e063-dadaa90a10e2Breakout Control

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49825-129BREAKOUT CONTROL BIOELEMENTS (BENZOYL PEROXIDE) CREAM [BIOELEMENTS, INC.]8Legacy NDC20240829_3546feee-7568-4b58-bb32-3dfcda7da694.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM3
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ43
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3
PHYTIC ACIDINACTIVE INGREDIENT7IGF0S7R8I3
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ43
SQUALANEINACTIVE INGREDIENTGW89575KF93
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49825-12949825-129-01, 49825-129-02
56152-4009

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii+route+dosage form
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
SQUALANESQUALANEGW89575KF9CREAM / TOPICAL6 %w/wExact identifier — unii+route+dosage form

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
48c37068-b129-faac-e063-6294a90ab6223546feee-7568-4b58-bb32-3dfcda7da6942026-01-19WarningsExact identifier
spl set id: 3546feee-7568-4b58-bb32-3dfcda7da694
Breakout Control BioelementsBENZOYL PEROXIDECosmetic Enterprises Ltd94462332-2169-4ea1-86b3-25ab9646c6e52025-10-10WarningsExact identifier
ndc (product): 56152-4009

Reported adverse events (FAERS/openFDA)#

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