FDA.reportPublic FDA data

Derma E Acne Cleansing Pads

Manufacturer
derma e | Topiderm, Inc. | Topiderm, Inc
Effective date
2024-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:03

Label at a glance#

ProductDerma E Acne Cleansing Pads
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

For the treatment of acne Helps keep skin clear of new acne, acne blemishes, acne pimples and blackheads

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1.9%

Purpose

OTC - PURPOSE SECTION

Anti-Acne

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne
  • Helps keep skin clear of new acne, acne blemishes, acne pimples and blackheads

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.

Warnings

WARNINGS SECTION

  • For external use only

OTC - WHEN USING SECTION

  • When using this product
  • 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, flush thoroughly with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Purified Water, Alcohol Denat., Glycolic Acid, Polysorbate 20, Azelaic Acid, Lactic Acid, Mandelic Acid, Salix Alba (Willow) Bark Extract, Chamomilla Recutita (Matricaria) Flower Extract, Lavandula Angustifolia (Lavender) Flower Extract, Panax Ginseng Root Extract, Cucumis Sativus (Cucumber) Fruit Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aniba Rosodora (Rosewood) Wood Oil, Lavandula Angustifolia (Lavender) Oil, Glycerin, Sodium Hydroxide, Sodium Phytate, Sodium Benzoate, Phenoxyethanol.

SPL UNCLASSIFIED SECTION

Distributed by DERMA E® • Simi Valley, CA 93065,
USA

PRINCIPAL DISPLAY PANEL - 50 mL Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DERMA•E

Anti-Acne Deep Cleansing Pads

Azelaic Acid, AHAs, BHAs & Anti-Blemish Complex
for face + body

• DERMATOLOGIST •
RECOMMENDED

100% VEGAN • SOY-FREE
ECO-ETHICAL
CRUELTY-FREE

50 PADS
(1.7 FL OZ / 50 mL)

PRINCIPAL DISPLAY PANEL - 50 mL Jar Label
PRINCIPAL DISPLAY PANEL - 50 mL Jar Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54108-3725-1Derma E Acne Cleansing Pads50 mL in 1 JARCLOTH501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54108-3725DERMA E ACNE CLEANSING PADS (SALICYLIC ACID) CLOTH [DERMA E]1Current NDC, 1 package rows20240530_c749a11f-daa1-4d76-b818-cd6509efaceb.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54108-372554108-3725-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCOLIC ACID0WT12SX38SIACT
POLYSORBATE 207T1F30V5YHIACT
AZELAIC ACIDF2VW3D43YTIACT
LACTIC ACID, DL-3B8D35Y7S4IACT
MANDELIC ACIDNH496X0UJXIACT
SALIX ALBA BARK205MXS71H7IACT
CHAMOMILEFGL3685T2XIACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
ASIAN GINSENGCUQ3A77YXIIACT
CUCUMBERYY7C30VXJTIACT
TEA TREE OILVIF565UC2GIACT
ROSEWOOD OILF2522O5L7BIACT
LAVENDER OILZBP1YXW0H8IACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHYTATE SODIUM88496G1ERLIACT
SODIUM BENZOATEOJ245FE5EUIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
Derma E Acne Cleansing PadsSALICYLIC ACIDderma ec749a11f-daa1-4d76-b818-cd6509efaceb2024-05-28WarningsExact identifier
ndc (package): 54108-3725-1
ndc (product): 54108-3725
ndc11 (package): 54108372501
spl id: 16a4e79d-5d46-4220-858b-6ed48fd664b7
spl set id: c749a11f-daa1-4d76-b818-cd6509efaceb

Reported adverse events (FAERS/openFDA)#

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