Derma E Acne Clarifying Mask Cream
FDA Label NDC 54108-3710

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Derma E for the product Derma E Acne Clarifying Mask (NDC 54108-3710). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, otc - do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Active Ingredient

Colloidal Sulfur 10.0%

Purpose

Anti-Acne

Uses

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

Warnings

For external use only

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.
  • Apply only to areas with acne.

Otc - Do Not Use

Do not use on

  • broken skin
  • large areas of the skin.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • 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

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?

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

Principal Display Panel - 57 G Tube Box

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)

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