FDA.reportPublic FDA data

Dr. Zenovia Spot Treatment

Manufacturer
Topiderm, Inc.
Effective date
2024-06-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:14:23

Label at a glance#

ProductDr. Zenovia Spot Treatment
Active ingredientBENZOYL PEROXIDE
Label structure11 sections

Indications and uses

For the treatment and management of acne Penetrates pores to eliminate most acne and blemishes Helps prevent development of new acne blemishes and blackheads

Dosage and administration

Blend a thin layer to affected area. Use once a day and increase to two or three times daily as needed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the treatment and management of acne
  • Penetrates pores to eliminate most acne and blemishes
  • Helps prevent development of new acne blemishes and blackheads

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 contact with eyes. If contact occurs, flush thoroughly with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Blend a thin layer to affected area.
  • Use once a day and increase to two or three times daily as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Bakuchiol, Camellia Sinensis (Green Tea) Polyphenols, Carbomer, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Punica Granatum Sterols, Purified Water, Resveratrol, Sodium Hydroxymethylglycinate, Sodium Lauroyl Sarcosinate, Genistein, Stearic Acid USP, Tocopheryl Acetate.

Questions?

OTC - QUESTIONS SECTION

Call (800) 445-2595 or visit drzenovia.com

REG-ulate360 Active Complex™

SPL UNCLASSIFIED SECTION

Resveratrol, Bakuchiol, Genistein, Camellia Sinensis (Green Tea) Polyphenols, Aloe Barbadensis Leaf Juice, Cucumis Sativus (Cucumber) Fruit Extract.

SPL UNCLASSIFIED SECTION

Distributed by Dr. Zenovia Skincare
Babylon, NY 11704

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DR. ZENOVIA
HORMONAL DERMATOLOGY

CLEAR COMPLEXION

5% BENZOYL PEROXIDE
ACNE SPOT TREATMENT

bakuchiol, antioxidants

reduces acne flare-ups
and redness

15 mL / 0.5 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 15 mL Bottle CartonPRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1488689benzoyl peroxide 5 % Topical SolutionPSN2
1488689benzoyl peroxide 50 MG/ML Topical SolutionSCD2
1488689benzoyl peroxide 5 % Topical SolutionSY2

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
51326-802-01Dr. Zenovia Spot Treatment1 in 1 BOXLIQUID12
51326-802-01Dr. Zenovia Spot Treatment15 mL in 1 BOTTLELIQUID152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-802DR. ZENOVIA SPOT TREATMENT (BENZOYL PEROXIDE) LIQUID [TOPIDERM, INC.]2Current NDC, 2 package rows20240628_dfdb3d8e-4d39-4ce4-851f-80b11972ca9e.zip

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
51326-80251326-802-01

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
BENZOYL PEROXIDEW9WZN9A0GMACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BAKUCHIOLOT12HJU3ARIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
CUCUMBERYY7C30VXJTIACT
GLYCERINPDC6A3C0OXIACT
PUNICA GRANATUM STEROLSUKV92KC49TIACT
WATER059QF0KO0RIACT
RESVERATROLQ369O8926LIACT
SODIUM HYDROXYMETHYLGLYCINATEDIG6BWZ9XTIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
GENISTEINDH2M523P0HIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT

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
Dr. Zenovia Spot TreatmentBENZOYL PEROXIDETopiderm, Inc.dfdb3d8e-4d39-4ce4-851f-80b11972ca9e2024-06-11WarningsExact identifier
ndc (package): 51326-802-01
ndc (product): 51326-802
ndc11 (package): 51326080201
spl id: 470d894e-af84-4370-880c-16725870d808
spl set id: dfdb3d8e-4d39-4ce4-851f-80b11972ca9e

Reported adverse events (FAERS/openFDA)#

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