iBlanc Restora-Bright Acne-Healing Cream

Manufacturer
iBlanc Inc.
Effective date
2012-08-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:33:03

Label at a glance#

ProductiBlanc Restora-Bright Acne Healing
Active ingredientBenzoyl Peroxide
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

USES: FOR THE TREATMENT OF ACNE

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:   Benzoyl Peroxide 5.25%

OTC - PURPOSE SECTION

Uses

  • for the treatment of acne

WARNINGS SECTION

Warnings

For external use only

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 one topical acne medication at a time.

OTC - DO NOT USE SECTION

Do not use if you

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

OTC - WHEN USING SECTION

When using this product

  • avoid unnecessary skin exposure and use a sunscreen
  • avoid contact with eyes, lips and mouth.  If eye contact accidentally occurs, rinse eyes throughly with water.
  • 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.

Stop use and ask a doctor if irritation becomes severe.

INACTIVE INGREDIENT SECTION

Inactive Ingredients Aqua (Water), Glycerin, Allantoin, Aloe Barbadensis Leaf Juice Powder, Acrylates/C13-30 Alkyl Acrylate Crosspolymer, Sorbitol, Sodium Hydroxide, Caprylyl Glycol, Phenoxyethanol

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 immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

iBlanc Dermaceuticals

RESTORA-BRIGHT
ACNE-HEALING
CREAM

Acne Healing Cream ART 2012-08-01_LBL
Acne Healing Cream ART 2012-08-01_LBL

DOSAGE & ADMINISTRATION SECTION

APPLY A THIN LAYER TO BLEMISHES DAILY AFTER CLEANSING SKIN. IF NEEDED AND NO DRYNESS OR PEELING OCCURS, USE FOR TOUCH-UP THROUGHOUT THE DAY.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1311503benzoyl peroxide 5.25 % Topical CreamPSN2
1311503benzoyl peroxide 52.5 MG/ML Topical CreamSCD2
1311503benzoyl peroxide 5.25 % Topical CreamSY2

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52960-101-122019-11-13C16284748780-197449f38-c8a5-f6ea-e053-dbdaa90aa703iBlanc Restora-Bright Acne-Healing Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52960-101-12iBlanc Restora-BrightAcne Healing45 g in 1 BOTTLE, PUMPCREAM452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52960-101IBLANC RESTORA-BRIGHT ACNE HEALING (BENZOYL PEROXIDE) CREAM [IBLANC INC.]2Legacy NDC, 1 package rows20120919_21e041cb-ef57-47f4-a3c9-692e22c510db.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GM2
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GM2
AllantoinINACTIVE INGREDIENT344S277G0Z2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U2
Carbomer Copolymer TYPE AINACTIVE INGREDIENT71DD5V995L2
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I2
SorbitolINACTIVE INGREDIENT506T60A25R2
WaterINACTIVE INGREDIENT059QF0KO0R2

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
52960-10152960-101-12

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 6 · 302 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ITABLET, FILM COATED / ORAL8 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISPONGE / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IFILM / BUCCAL0.09 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET / SUBLINGUAL50.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / RETROBULBARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / PERIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IMOUTHWASH / BUCCAL2 mg/1mlExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICONCENTRATE / ORAL10 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IELIXIR / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IPASTE / DENTAL0.6 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISYRUP / ORAL71 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-AMNIOTICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISPRAY / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IFILM, EXTENDED RELEASE / TRANSDERMAL0.85 mgExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ORAL9 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SOLUTION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / AURICULAR (OTIC)0.8 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii candidate
44 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION, SOLUTION / INTRAVENOUS4050 mgExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 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
46279779-1009-4416-a80a-f3f94ada7d9f21e041cb-ef57-47f4-a3c9-692e22c510db2012-08-18WarningsExact identifier
spl id: 46279779-1009-4416-a80a-f3f94ada7d9f
spl set id: 21e041cb-ef57-47f4-a3c9-692e22c510db

Reported adverse events (FAERS/openFDA)#

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