DERMA E ACNE CLEANSING PADS- salicylic acid cloth

Derma E Acne Cleansing Pads by

Drug Labeling and Warnings

Derma E Acne Cleansing Pads 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]

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Drug Facts

Active Ingredients

Salicylic Acid 1.9%

Purpose

Anti-Acne

Uses

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

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.

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.

Inactive ingredients:

Purified Water, Alcohol Denat., Glycolic Acid, Polysorbate 20, Azelaic Acid, Lactic Acid, Mandelic Acid, Salix Alba (Willow) Bark Extract, Chamomilla Recutita (Matricaria) Flower Extract, Lavandula Angustifolia (Lavender) Flower Extract, Panax Ginseng Root Extract, Cucumis Sativus (Cucumber) Fruit Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aniba Rosodora (Rosewood) Wood Oil, Lavandula Angustifolia (Lavender) Oil, Glycerin, Sodium Hydroxide, Sodium Phytate, Sodium Benzoate, Phenoxyethanol.

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

PRINCIPAL DISPLAY PANEL - 50 mL Jar Label

DERMAE

Anti-Acne Deep Cleansing Pads

Azelaic Acid, AHAs, BHAs & Anti-Blemish Complex
for face + body

DERMATOLOGIST
RECOMMENDED

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

50 PADS
(1.7 FL OZ / 50 mL)

INGREDIENTS AND APPEARANCE

DERMA E ACNE CLEANSING PADS 
salicylic acid cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-3725
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	190 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCOLIC ACID (UNII: 0WT12SX38S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
AZELAIC ACID (UNII: F2VW3D43YT)
LACTIC ACID, DL- (UNII: 3B8D35Y7S4)
MANDELIC ACID (UNII: NH496X0UJX)
SALIX ALBA BARK (UNII: 205MXS71H7)
CHAMOMILE (UNII: FGL3685T2X)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
ASIAN GINSENG (UNII: CUQ3A77YXI)
CUCUMBER (UNII: YY7C30VXJT)
TEA TREE OIL (UNII: VIF565UC2G)
ROSEWOOD OIL (UNII: F2522O5L7B)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHYTATE SODIUM (UNII: 88496G1ERL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54108-3725-1	50 mL in 1 JAR; Type 0: Not a Combination Product	05/23/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M006	05/23/2024

Labeler - derma e (148940450)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc		049121643	MANUFACTURE(54108-3725)