FDA.reportPublic FDA data

Dermesse Pad Treatment 2.0

Manufacturer
Axia Medical Solutions, LLC | Sanitor Corporation
Effective date
2022-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:56

Label at a glance#

ProductDermesse Pad Treatment 0.5
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

For the treatment of acne

Dosage and administration

Cleanse the skin thoroughly before applying medication 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 directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

0.5% Salicylic Acid

2% Salicylic Acid

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses:

INDICATIONS & USAGE SECTION

For the treatment of acne

Warninigs:

WARNINGS SECTION

For external use only

Combustibles. Keep away from fire or flames.

Ask a doctor or pharmacist before use if you are:

OTC - ASK DOCTOR/PHARMACIST SECTION

using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs only one medication should be used unless directed by a doctor.

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

  • Cleanse the skin thoroughly before applying medication
  • 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 directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

Store at controlled room temperature 15-300C (59-860F), away from diret sunlight.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Ammonium Hydroxide, Edetate Disodium, Ethyl Alcohol SD40, Glycolic Acid, Propylene Glycol, Purified Water, Nonoxynol 9.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermesse Pad Treatment 0.5

Dermesse_AcnePads_0.5%Dermesse_AcnePads_0.5%

Dermesse Pad Treatment 2.0

Dermesse_AcnePads_2.0%Dermesse_AcnePads_2.0%

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68723-400-052024-01-30C16284748780-11030e365-584f-111a-e063-dadaa90a10e2Dermesse Pad Treatment
68723-401-202024-01-30C16284748780-11030e365-584f-111a-e063-dadaa90a10e2Dermesse Pad Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68723-400-05Dermesse Pad Treatment 0.560 in 1 PACKAGELOTION601
68723-401-20Dermesse Pad Treatment 2.060 in 1 PACKAGELOTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68723-400DERMESSE PAD TREATMENT 0.5 (0.5%SALICYLIC ACID) LOTION DERMESSE PAD TREATMENT 2.0 (2%SALICYLIC ACID) LOTION [AXIA MEDICAL SOLUTIONS, LLC]1Legacy NDC, 1 package rows20220115_959c44cd-c067-4bd1-b46b-5fccf4802ef7.zip
68723-401DERMESSE PAD TREATMENT 0.5 (0.5%SALICYLIC ACID) LOTION DERMESSE PAD TREATMENT 2.0 (2%SALICYLIC ACID) LOTION [AXIA MEDICAL SOLUTIONS, LLC]1Legacy NDC, 1 package rows20220115_959c44cd-c067-4bd1-b46b-5fccf4802ef7.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68723-40068723-400-05
68723-40168723-401-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
EDETATE DISODIUM7FLD91C86KIACT
GLYCOLIC ACID0WT12SX38SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
NONOXYNOL-948Q180SH9TIACT
WATER059QF0KO0RIACT
AMMONIA5138Q19F1XIACT
ALCOHOL3K9958V90MIACT
SALICYLIC ACIDO414PZ4LPZACTIB
EDETATE DISODIUM7FLD91C86KIACT
GLYCOLIC ACID0WT12SX38SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
NONOXYNOL-948Q180SH9TIACT
WATER059QF0KO0RIACT
AMMONIA5138Q19F1XIACT
ALCOHOL3K9958V90MIACT

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
c9ec196d-bd55-470d-9165-836c54c7cd81959c44cd-c067-4bd1-b46b-5fccf4802ef72022-01-11WarningsExact identifier
spl id: c9ec196d-bd55-470d-9165-836c54c7cd81
spl set id: 959c44cd-c067-4bd1-b46b-5fccf4802ef7

Reported adverse events (FAERS/openFDA)#

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