Biba Acne

Manufacturer
Esthetic Underground, Inc. | Product Society LLC
Effective date
2025-03-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:51

Label at a glance#

ProductBiba Acne
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Indications and uses

For the treatment of acne

Dosage and administration

Clean the skin thoroughly before applying this product Cover the entire affected area with a thin layer one to three times daily Because excessive dryness of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor If bothersome dryness of peeling occurs, reduce application to once a day every other day

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 2.5%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • On sensitive skin
  • If you are allergic to benzoyl peroxide

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you havesevere acne

When using this product

OTC - WHEN USING SECTION

Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time

  • If irritation occurs, use one topical acne medication at a time
  • Avoid contact with eyes, lips & 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
  • Avoid unnecessary sun exposure and use sunscreen.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Irritation becomes severe.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call a poison control center or get medical help right away

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the skin thoroughly before applying this product

  • Cover the entire affected area with a thin layer one to three times daily
  • Because excessive dryness of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor
  • If bothersome dryness of peeling occurs, reduce application to once a day every other day

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Cetearyl Alcohol, Cetearyl Glucoside, Pentylene Glycol, Propanediol, Caprylyl Glycol, Ethylhexylglycerin, Chlorphenesin, Carbomer, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Sodium Hydroxide, Citric Acid.

Questions?

OTC - QUESTIONS SECTION

01+ 310-770-5831

hello@bibalosangeles.com

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIBA
DE SOUSA
LOS ANGELES

THE
ACNE GEL

Net wt. 1.02 fl. oz. / 30 mL

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308689benzoyl peroxide 2.5 % Topical GelPSN2
308689benzoyl peroxide 0.025 MG/MG Topical GelSCD2
308689benzoyl peroxide 2.5 % Topical GelSY2

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
83834-001-01Biba Acne30 mL in 1 BOTTLE, PUMPGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83834-001BIBA ACNE (BENZOYL PEROXIDE) GEL [ESTHETIC UNDERGROUND, INC.]21 package rows20250309_448eeb45-e6a2-43da-bd04-9844aa0b5dff.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
83834-00183834-001-01

Ingredients#

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

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

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
2fc8f2d1-1146-7720-e063-6294a90a7467448eeb45-e6a2-43da-bd04-9844aa0b5dff2025-03-07WarningsExact identifier
spl id: 2fc8f2d1-1146-7720-e063-6294a90a7467
spl set id: 448eeb45-e6a2-43da-bd04-9844aa0b5dff

Reported adverse events (FAERS/openFDA)#

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