FDA.reportPublic FDA data

Asepxia Acne Wipes

Manufacturer
Genomma Lab USA
Effective date
2022-01-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:13:15

Label at a glance#

ProductAsepxia Acne Wipes
Active ingredientSalicylic Acid
Label structure11 sections

Dosage and administration

Cleanse face and rinse thoroughly before applying product. Wipe pad over face and neck covering the affected area with a thin layer 1 to 3 times daily. Because excessive drying of skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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. Sensitivity...

Storage and handling

store in a cool, dry place keep lid tightly closed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

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. If this occurs, use only one topical acne medication at a time unless directed by a doctor.
  • Avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if 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

  • Cleanse face and rinse thoroughly before applying product.
  • Wipe pad over face and neck covering the affected area with a thin layer 1 to 3 times daily.
  • Because excessive drying of skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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.
  • Sensitivity test for new user: Apply product sparingly to 1 or 2 small affected areas during the first 3 days. If no discomfort occurs, follow directions stated above.

Other information

STORAGE AND HANDLING SECTION

  • store in a cool, dry place
  • keep lid tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Hamamelis Virginiana Extract, Caprylyl/Capryl Glucoside, Charcoal Powder, Glycerin, Sodium Hydroxide, Phenoxyethanol, Sodium Benzoate, Citric acid, Parfum.

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 - 20 WIPE Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

Asepxia®

ACNE WIPES

PURIFY YOUR SKIN
Removes impurities on skin surface

Open

with the power of
Salicylic Acid.
+ ACTIVATED CHARCOAL

Dermatologically tested

20 WIPES
7.4 x 7.2 in (18.7x18.2 cm)

PRINCIPAL DISPLAY PANEL - 20 WIPE Pouch
PRINCIPAL DISPLAY PANEL - 20 WIPE Pouch

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-06250066-062-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
GlycerinPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
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
6487beab-4843-487a-bca9-eea91afdacf5994a4396-5e2e-4d6c-8a08-ddc020e862f72024-01-12WarningsExact identifier
spl set id: 994a4396-5e2e-4d6c-8a08-ddc020e862f7

Reported adverse events (FAERS/openFDA)#

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