FDA.reportPublic FDA data

SMART RELEASE BPO

Manufacturer
SkinClinical AI, LLC
Effective date
2019-06-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:49

Label at a glance#

ProductSMART RELEASE BPO 5 PERCENT
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Dosage and administration

IMPORTANT TO USE ON A CLEAN FACE. COVER THE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES PER DAY. BECAUSE OF EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION PER DAY THEN GRADUALLY INCREASE TO TWO APPLICATIONS PER DAY, ONE MORNING AND ONE EVENING IF NEEDED, OR AS DIRECTED BY A DOCTOR. IF DRYNESS OR PEELING OCCURS, REDUCE USE TO ONCE A DAY OR ONCE EVERY OTHER DAY. IF GOING OUTSIDE, USE A SUN...

Label contents#

Full prescribing information#

PURPOSE

OTC - PURPOSE SECTION

TREATMENT OF ACNE

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

BENZOYL PEROXIDE 5%

USE

INDICATIONS & USAGE SECTION

FOR THE TREATMENT OF ACNE

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

OTC - WHEN USING SECTION

  • WHEN USING THIS PRODUCT 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 1 TOPICAL ACNE MEDICATION AT A TIME.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN. AVOID CONTACT WITH THE EYES, LIPS AND MOUTH. SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHINH, 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 OR SENSITIVE TO BENZOYL PEROXIDE.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or sensitivity develops.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Keep tightly closed.
Protect from excessive heat (40°/140° F) and protect from freezing.

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

IMPORTANT TO USE ON A CLEAN FACE. COVER THE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES PER DAY. BECAUSE OF EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION PER DAY THEN GRADUALLY INCREASE TO TWO APPLICATIONS PER DAY, ONE MORNING AND ONE EVENING IF NEEDED, OR AS DIRECTED BY A DOCTOR. IF DRYNESS OR PEELING OCCURS, REDUCE USE TO ONCE A DAY OR ONCE EVERY OTHER DAY. IF GOING OUTSIDE, USE A SUNSCREEN. IF IRRITATION OR SENSITIVITY DEVELOPS STOP USING BOTH PRODUCTS AND ASK A DOCTOR.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-8 SMDI Copolymer, Lactobacillus Ferment, Glycolic Acid, Lactic Acid, Magnesium Aluminum Silicate, Citric Acid, Xanthan Gum, Potassium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Hydrolyzed Algin, Zinc Sulfate, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil.Citrus Tangerina (Tangerine) Peel Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_SC_AI_Smart Release BPO 5pct01b LBL_SC_AI_Smart Release BPO 5pct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106309benzoyl peroxide 5 % Topical LotionPSN2
106309benzoyl peroxide 50 MG/ML Topical LotionSCD2
106309benzoyl peroxide 5 % Topical LotionSY2

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73110-102-112021-01-29C16284748780-1ba0f9c33-1d0c-a910-e053-dadaa90a0b85SMART RELEASE BPO 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73110-102-11SMART RELEASE BPO5 PERCENT30 mL in 1 BOTTLE, DISPENSINGLOTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73110-102SMART RELEASE BPO 5 PERCENT (BENZOYL PEROXIDE) LOTION [SKINCLINICAL AI, LLC]2Legacy NDC, 1 package rows20190709_8d2f3dfd-d821-dfc6-e053-2995a90a23f8.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73110-10273110-102-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
PEG-8/SMDI COPOLYMERCCX72L6NY6IACT
LACTOBACILLUS REUTERI9913I24QEEIACT
GLYCOLIC ACID0WT12SX38SIACT
LACTIC ACID33X04XA5ATIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
XANTHAN GUMTTV12P4NEEIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM ALGINATEC269C4G2ZQIACT
ZINC SULFATE89DS0H96TBIACT
EDETATE DISODIUM7FLD91C86KIACT
BERGAMOT OIL39W1PKE3JIIACT
GRAPEFRUIT OILYR377U58W9IACT
ORANGE OILAKN3KSD11BIACT
TANGERINE PEELJU3D414057IACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8d2f0715-6734-55a6-e053-2995a90ac63f8d2f3dfd-d821-dfc6-e053-2995a90a23f82019-06-29WarningsExact identifier
spl id: 8d2f0715-6734-55a6-e053-2995a90ac63f
spl set id: 8d2f3dfd-d821-dfc6-e053-2995a90a23f8

Reported adverse events (FAERS/openFDA)#

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