Asepxia Charcoal Acne Bar

Manufacturer
Genomma Lab USA
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:29

Label at a glance#

ProductAsepxia Charcoal Acne Bar
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

For the treatment of acne Reduces the number of acne pimples Allows skin to heal Penetrates pores to clear most acne blemishes Dries up acne pimples Helps keep skin clear of new acne blemishes, acne pimples, whiteheads and blackheads

Dosage and administration

Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne. Rinse thoroughly and pat dry with a clean towel. If bothersome dryness or peeling occurs, reduce application to every other day.

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid, 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne
  • Reduces the number of acne pimples
  • Allows skin to heal
  • Penetrates pores to clear most acne blemishes
  • Dries up acne pimples
  • Helps keep skin clear of new acne blemishes, acne pimples, whiteheads and blackheads

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

, skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a doctor. Avoid contact with eyes. If product gets in eyes, rinse with water. When using this product

OTC - STOP USE SECTION

excessive skin irritation occurs Stop use and ask a doctor if

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne.
  • Rinse thoroughly and pat dry with a clean towel.
  • If bothersome dryness or peeling occurs, reduce application to every other day.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sodium Palmate, Sodium Cocoate and/or Sodium Palm Kernelate, Water, Glycerin, Activated Charcoal, Sodium Chloride, Iron Oxide (CI 77499), Pentasodium Pentetate

OTC - QUESTIONS SECTION

For more product information, please call Toll Free: 1 877 99 GENOM (43666)

SPL UNCLASSIFIED SECTION

Distributed by: Genomma Lab USA Inc., Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 113 g Bar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW FORMULA

COMBINATION SKIN WITH IMPERFECTIONS

Asepxia ®

Acne Bar Soap

Charcoal PURIFYING EFFECT

2% Salicylic Acid

> With Activated Charcoal

> Removes toxins and impurities on skin surface

> Oily skin control

Net Wt. 4 oz (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Bar Carton
PRINCIPAL DISPLAY PANEL - 113 g Bar Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312882salicylic acid 2 % Medicated Bar SoapPSN4
312882salicylic acid 0.02 MG/MG Medicated Bar SoapSCD4
312882salicylic acid 2 % Medicated Bar SoapSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-801-012020-03-23C16284748780-19d75b9cf-e4dd-f424-e053-dadaa90a57ceAsepxia Charcoal Acne Bar Soap ®
50066-801-012020-01-31C16284748780-19d75b9cf-e4dd-f424-e053-dadaa90a57ceAsepxia Charcoal Acne Bar Soap ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-801-01Asepxia Charcoal Acne Bar1 in 1 CARTONSOAP14
50066-801-01Asepxia Charcoal Acne Bar113 g in 1 APPLICATORSOAP1134

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-801ASEPXIA CHARCOAL ACNE BAR (SALICYLIC ACID) SOAP [GENOMMA LAB USA]4Current NDC, Legacy NDC, 2 package rows20231108_f727d947-fa91-47ae-8ea5-948afc9e5ba8.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-80150066-801-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
Asepxia Charcoal Acne BarSALICYLIC ACIDGenomma Lab USAf727d947-fa91-47ae-8ea5-948afc9e5ba82023-11-06WarningsExact identifier
ndc (package): 50066-801-01
ndc (product): 50066-801
ndc11 (package): 50066080101
spl id: 09891759-b170-6a81-e063-6394a90a2f89
spl set id: f727d947-fa91-47ae-8ea5-948afc9e5ba8

Reported adverse events (FAERS/openFDA)#

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