FDA.reportPublic FDA data

Asepxia ® Acne Treatment Cream Acne Treatment

Manufacturer
Genomma Lab USA Inc. | Garcoa, Inc. | Sigan Industries INC
Effective date
2024-11-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:50:05

Label at a glance#

ProductAsepxia Acne Treatment
Active ingredientBenzoyl Peroxide
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 going outsi...

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

Benzoyl Peroxide 10%

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

Do not use

OTC - DO NOT USE SECTION

  • if you have very sensitive skin
  • if you are sensitive to benzoyl peroxide

When using this product

OTC - WHEN USING SECTION

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • 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 medication at a time
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using this product less frequently or at a lower concentration

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, 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 going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor

Sensitivity test for new user

SPL UNCLASSIFIED SECTION

  • 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

carbomer, disodium EDTA, hydroxypropyl methylcellulose, Laureth-4, sodium hydroxide, 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 77027

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Asepxia®

ACNE TREATMENT CREAM

10% BENZOYL PEROXIDE

> ELIMINATES MOST PIMPLES AND BLACKHEADS

NET WT./ CONT. NET.
1 OZ (28 g)

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

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
50066-05250066-052-01

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
Benzoyl PeroxideW9WZN9A0GMACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
Edetate Disodium7FLD91C86KIACT
Hypromellose, Unspecified3NXW29V3WOIACT
Laureth-46HQ855798JIACT
Sodium Hydroxide55X04QC32IIACT
Water059QF0KO0RIACT

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
99515059-4a2e-4176-99c2-30827fdbde5daddefc6f-3a0a-4470-a4e8-a9398d3540052025-02-25WarningsExact identifier
spl set id: addefc6f-3a0a-4470-a4e8-a9398d354005

Reported adverse events (FAERS/openFDA)#

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