FDA.reportPublic FDA data

Derma E Acne Blemish Control Treatment Serum

Manufacturer
derma e | Topiderm, Inc. | Topiderm, Inc
Effective date
2024-04-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:53

Label at a glance#

ProductDerma E Acne Blemish Control Treatment Serum
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

SHAKE WELL 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

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.
  • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • SHAKE WELL
  • 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Hydroxypropyl Starch Phosphate (Sugar Starch), Salix Alba (Willow) Bark Extract, Epilobium Angustifolium (Canadian Willowherb) Extract, Aniba Rosodora (Rosewood) Wood Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Niacinamide (Vitamin B3), Organic Camellia Sinensis (Green Tea) Leaf Extract1, Aloe Barbadensis (Aloe Vera) Leaf Juice1, Caffeine, Hamamelis Virginiana (Witch Hazel) Extract, Lavandula Angustifolia (Lavender) Oil, Carrageenan (Seaweed Derived), Citric Acid, Potassium Hydroxide, Polysorbate 20, Xanthan Gum, Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin.

1 Certified Organic Ingredients

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 60 mL Jar Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTI-ACNE

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

DERMA • E

Acne Blemish
Control
Treatment
Serum

Active Salicylic Acid
Tea Tree Oil
Aloe Vera

reduces acne,
blackheads and breakouts

• DERMATOLOGIST •
RECOMMENDED

2 FL OZ / 60 mL

Principal Display Panel - 60 mL Jar Box
Principal Display Panel - 60 mL Jar Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54108-3851-1Derma E Acne Blemish Control Treatment Serum60 mL in 1 JARLIQUID601
54108-3851-1Derma E Acne Blemish Control Treatment Serum1 in 1 BOXLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54108-3851DERMA E ACNE BLEMISH CONTROL TREATMENT SERUM (SALICYLIC ACID) LIQUID [DERMA E]1Current NDC, 2 package rows20240502_bf5f489d-07c6-47b8-ae76-701e7ad92e8d.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54108-385154108-3851-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
EPILOBIUM ANGUSTIFOLIUM WHOLEC278QS9YBTIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
HYDROXYPROPYL CORN AMYLOPECTIN, PHOSPHATE CROSSLINKED (4000 MPA.S AT 5%)GSS77345H7IACT
PHENOXYETHANOLHIE492ZZ3TIACT
NIACINAMIDE25X51I8RD4IACT
CARRAGEENAN5C69YCD2YJIACT
POLYSORBATE 207T1F30V5YHIACT
TEA TREE OILVIF565UC2GIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAFFEINE3G6A5W338EIACT
LAVENDER OILZBP1YXW0H8IACT
SALIX ALBA BARK205MXS71H7IACT
ROSEWOOD OILF2522O5L7BIACT

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 Blemish Control Treatment SerumSALICYLIC ACIDderma ebf5f489d-07c6-47b8-ae76-701e7ad92e8d2024-04-30WarningsExact identifier
ndc (package): 54108-3851-1
ndc (product): 54108-3851
ndc11 (package): 54108385101
spl id: 589bd6d4-fddc-4142-aecb-ab3e30dcdd2c
spl set id: bf5f489d-07c6-47b8-ae76-701e7ad92e8d

Reported adverse events (FAERS/openFDA)#

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