Derma E Acne Clarifying Mask

Manufacturer
derma e | Topiderm, Inc. | Topix Pharmaceuticals, Inc.
Effective date
2023-02-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:24:14

Label at a glance#

ProductDerma E Acne Clarifying Mask
Active ingredientSULFUR
Label structure10 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

New User: Apply product sparingly to one or two affected areas.Test for the first 3 days. If you do not experience any discomfort, Follow instructions below. Apply to clean face, avoiding the eye and lip area. Cover the entire affected area with a thin layer. Leave on for 10-15 minutes. Rinse thoroughly with warm water or remove with a damp cloth. Pat skin dry. Apply 2-3 times a week.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Sulfur 10.0%

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.
  • Apply only to areas with acne.

OTC - DO NOT USE SECTION

Do not use on

  • broken skin
  • large areas of the skin.

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

  • New User: Apply product sparingly to one or two affected areas.Test for the first 3 days. If you do not experience any discomfort, Follow instructions below.
  • Apply to clean face, avoiding the eye and lip area.
  • Cover the entire affected area with a thin layer.
  • Leave on for 10-15 minutes. Rinse thoroughly with warm water or remove with a damp cloth.
  • Pat skin dry. Apply 2-3 times a week.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Bentonite, Kaolin, Glycerin (Vegetable Derived), Diatomaceous Earth, Allantoin, Niacinamide, Zinc PCA, Glycosaminoglycans, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Bakuchiol, Zinc Oxide, Camellia Sinensis Leaf Extract, Sodium Alginate, Daucus Carota Sativa (Carrot) Seed Oil, Bois de Rose (Rosewood) Oil, Bromelain, Salix Alba (Willow) Bark Extract, Papain, Rosmarinus Officinalis (Rosemary) Leaf Extract, Resveratrol, Humulus Lupulus (Hops) Extract, Yeast Extract, Iron Oxide (CI 77492), Camphor, Lavendula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citric Acid, Phenoxyethanol.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-933-9344
or visit dermae.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 57 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTI-ACNE

100% VEGAN • SOY-FREE
CRUELTY-FREE

ECO-ETHICAL

DERMA • E

Acne Sulfur
Clarifying Mask

10% Colloidal Sulfur
Bentonite Clay
Willow Bark Extract

targets pores, acne
and controls oil

• DERMATOLOGIST
RECOMMENDED •

2 OZ / 57 g

PRINCIPAL DISPLAY PANEL - 57 g Tube Box
PRINCIPAL DISPLAY PANEL - 57 g Tube Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
315220sulfur 10 % Topical CreamPSN4
315220sulfur 100 MG/ML Topical CreamSCD4
315220sulfur 10 % Topical CreamSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54108-3710-5Derma E Acne Clarifying Mask57 g in 1 TUBECREAM574
54108-3710-5Derma E Acne Clarifying Mask1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54108-3710DERMA E ACNE CLARIFYING MASK (SULFUR) CREAM [DERMA E]4Current NDC, 2 package rows20241012_55df8fb4-abc3-43fe-b89b-6e7d638b27a6.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54108-371054108-3710-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

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 Clarifying MaskSULFURderma e55df8fb4-abc3-43fe-b89b-6e7d638b27a62023-02-14WarningsExact identifier
ndc (package): 54108-3710-5
ndc (product): 54108-3710
ndc11 (package): 54108371005
spl id: 68dab638-c1b8-46f6-853b-6ec16bfa8447
spl set id: 55df8fb4-abc3-43fe-b89b-6e7d638b27a6

Reported adverse events (FAERS/openFDA)#

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