DERMA E ACNE CLARIFYING MASK- sulfur cream

Derma E Acne Clarifying Mask by

Drug Labeling and Warnings

Derma E Acne Clarifying Mask by is a Otc medication manufactured, distributed, or labeled by derma e, Topiderm, Inc., Topix Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

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.

Do not use on

• broken skin
• large areas of the skin.

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

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

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

INGREDIENTS AND APPEARANCE

DERMA E ACNE CLARIFYING MASK 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-3710
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
KAOLIN (UNII: 24H4NWX5CO)
BENTONITE (UNII: A3N5ZCN45C)
GLYCERIN (UNII: PDC6A3C0OX)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
ALLANTOIN (UNII: 344S277G0Z)
NIACINAMIDE (UNII: 25X51I8RD4)
ZINC PIDOLATE (UNII: C32PQ86DH4)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
BAKUCHIOL (UNII: OT12HJU3AR)
ZINC OXIDE (UNII: SOI2LOH54Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
CARROT SEED OIL (UNII: 595AO13F11)
ROSEWOOD OIL (UNII: F2522O5L7B)
BROMELAINS (UNII: U182GP2CF3)
SALIX ALBA BARK (UNII: 205MXS71H7)
PAPAIN (UNII: A236A06Y32)
ROSEMARY (UNII: IJ67X351P9)
RESVERATROL (UNII: Q369O8926L)
HOPS (UNII: 01G73H6H83)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
FERROUS OXIDE (UNII: G7036X8B5H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
XANTHAN GUM (UNII: TTV12P4NEE)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54108-3710-5	1 in 1 BOX	12/14/2022
1		57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M006	12/14/2022

Labeler - derma e (148940450)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(54108-3710)

Establishment
Name	Address	ID/FEI	Business Operations
Topix Pharmaceuticals, Inc.		117745066	PACK(54108-3710)