FDA.reportPublic FDA data

Asepxia Liquid Acne Cleanser

Manufacturer
Genomma Lab USA
Effective date
2019-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:35

Label at a glance#

ProductAsepxia Liquid Acne Cleanser
Active ingredientSalicylic Acid
Label structure11 sections

Indications and uses

Helps clear up acne blemishes Penetrates pores to control acne blemishes Helps prevent new acne blemishes from forming

Dosage and administration

Use daily on skin prone to acne. Apply to wet skin with a clean wash cloth or body puff. 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 1.0%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • Helps clear up acne blemishes
  • Penetrates pores to control acne blemishes
  • Helps prevent new acne blemishes from forming

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, rinse thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If excessive skin irritation occurs.

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

  • Use daily on skin prone to acne.
  • Apply to wet skin with a clean wash cloth or body puff. 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

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, Sorbitol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Laureth-4, Fragrance, Menthol, Sodium Hydroxide, Polyquaternium-39, Disodium EDTA, Charcoal Powder, Sodium Benzoate, Benzyl Alcohol, Benzoic Acid, Sorbic Acid.

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-877-99-GENOM (43666) Monday to Friday, 8am to 6pm, Central time.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 224 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

Asepxia®

LIQUID ACNE CLEANSER

PURIFY YOUR SKIN
Removes impurities on skin surface

With the power of
Salicylic Acid.

+ ACTIVATED
CHARCOAL

Oil Free

7.6 FL OZ
(224 mL)

2000008253

PRINCIPAL DISPLAY PANEL - 224 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 224 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038982salicylic acid 1 % Medicated Liquid SoapPSN1
1038982salicylic acid 10 MG/ML Medicated Liquid SoapSCD1
1038982salicylic acid 1 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-060-012022-01-28C16284748780-1d6a99b39-d24b-a426-e053-dadaa90af4c2Asepxia ® Liquid Acne Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-060-01Asepxia Liquid Acne Cleanser224 mL in 1 BOTTLE, PLASTICLOTION2241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-060ASEPXIA LIQUID ACNE CLEANSER (SALICYLIC ACID) LOTION [GENOMMA LAB USA]1Legacy NDC, 1 package rows20190927_70b49744-ecb8-49d9-a2b2-789d5f35dfc7.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-06050066-060-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
Sodium Laureth-3 SulfateBPV390UAP0IACT
GlycerinPDC6A3C0OXIACT
Sorbitol506T60A25RIACT
Cocamidopropyl betaine5OCF3O11KXIACT
Laureth-46HQ855798JIACT
Activated Charcoal2P3VWU3H10IACT

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
e419fb99-02aa-4b0f-88f2-52fca8c2ddae70b49744-ecb8-49d9-a2b2-789d5f35dfc72019-09-26WarningsExact identifier
spl id: e419fb99-02aa-4b0f-88f2-52fca8c2ddae
spl set id: 70b49744-ecb8-49d9-a2b2-789d5f35dfc7

Reported adverse events (FAERS/openFDA)#

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