DERMA E ACNE MATTE MOISTURIZER- salicylic acid lotion

Derma E Acne Matte Moisturizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Salicylic Acid 0.53%

Purpose

Acne Treatment

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.

Keep out of reach of children.

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

Directions

• 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

Purified Water, Stearic Acid (Vegetable Derived), Caprylic/Capric Triglyceride (Vegetable Derived), Cetyl Alcohol (Plant Derived), Glyceryl Stearate Citrate (Vegetable Derived), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Glycerin (Vegetable Derived), Polysorbate 60, Salix Alba (Willow) Bark Extract, Aniba Rosodora (Rosewood) Wood Oil, Organic Simmondsia Chinensis (Jojoba) Seed Oil*, Organic Chamomilla Recutita (Matricaria) Flower Extract1, Organic Aloe Barbadensis (Aloe Vera) Extract*, Allantoin, Panthenol (Provitamin B5), Xanthan Gum, Polysorbate 20, Glyceryl Stearate (Vegetable Derived), Cetearyl Glucoside (Plant Derived), Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin, Lavandula Angustifolia (Lavender) Oil.

1 Certified Organic Ingredients

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 56 g Tube Box

ANTI-ACNE

SAME EFFECTIVE
FORMULA
New
Look!

DERMAE
Acne Oil-Control
Matte Moisturizer

Active Salicylic Acid
Tea Tree Oil & Aloe Vera
rebalances sebum production

DERMATOLOGIST
RECOMMENDED

2 OZ / 56 g

INGREDIENTS AND APPEARANCE

DERMA E ACNE MATTE MOISTURIZER 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-3900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
TEA TREE OIL (UNII: VIF565UC2G)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SALIX ALBA BARK (UNII: 205MXS71H7)
ROSEWOOD OIL (UNII: F2522O5L7B)
JOJOBA OIL (UNII: 724GKU717M)
CHAMOMILE (UNII: FGL3685T2X)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54108-3900-1	1 in 1 BOX	05/21/2021
1		56 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	05/21/2021

Labeler - derma e (148940450)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc		049121643	MANUFACTURE(54108-3900)