FDA.reportPublic FDA data

Asepxia® Acne Treatment Cream

Manufacturer
Genomma Lab USA
Effective date
2024-10-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:23:47

Label at a glance#

ProductAsepxia Acne Treatment
Active ingredientSALICYLIC ACID
Label structure11 sections

Indications and uses

for the treatment of acne dries and clears acne blemishes penetrates pores to eliminate most acne blemishes helps prevent new acne blemishes

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 drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day If irritation or sensiti...

Storage and handling

Keep tightly closed Store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicilic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of acne
  • dries and clears acne blemishes
  • penetrates pores to eliminate most acne blemishes
  • helps prevent new acne blemishes

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 acne medication at the same time. If irritation occurs, use only one topical acne med cation at a time

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

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • If irritation or sensitivity develops, stop use and ask a doctor

Sensitivity test for new user

  • apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above

Other information

STORAGE AND HANDLING SECTION

  • Keep tightly closed
  • Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylamide Sodium Acrylate Copolymer, Cyclopentasiloxane, Ethylhexylglycerin, Glycerin, Paraffinum Liquid, Phenoxyethanol, Polysorbate 20, Propylene glycol, Sodium Citrate, Trideceth-6, Water.

Questions or comments?

OTC - QUESTIONS SECTION

1 877 994 3666. Monday to Friday, 8am to 6pm, Central time.

SPL UNCLASSIFIED SECTION

Distributed by: Genomma Lab USA Inc., Houston, TX 77098

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Asepxia®

ACNE TREATMENT CREAM

2 % SALICYLIC ACID

ELIMINATES MOST PIMPLES AND BLACKHEADS

NET WT.
1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317152salicylic acid 2 % Topical CreamPSN3
317152salicylic acid 20 MG/ML Topical CreamSCD3
317152salicylic acid 2 % Topical CreamSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-064-01Asepxia Acne Treatment1 in 1 CARTONCREAM13
50066-064-01Asepxia Acne Treatment28 g in 1 TUBECREAM283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-064ASEPXIA ACNE TREATMENT (SALICYLIC ACID) CREAM [GENOMMA LAB USA]3Current NDC, 2 package rows20241010_910d4320-bf89-436a-a8d4-54d001281dee.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
50066-06450066-064-01

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
CYCLOMETHICONE 50THT5PCI0RIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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 Acne TreatmentSALICYLIC ACIDGenomma Lab USA910d4320-bf89-436a-a8d4-54d001281dee2024-10-08WarningsExact identifier
ndc (package): 50066-064-01
ndc (product): 50066-064
ndc11 (package): 50066006401
spl id: 23f810d6-c9d8-4ef6-e063-6294a90aeaf2
spl set id: 910d4320-bf89-436a-a8d4-54d001281dee

Reported adverse events (FAERS/openFDA)#

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