Drug Facts

Active Ingredient

Salicylic Acid 2%

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

Moisten face and apply by massaging face gently, avoiding the delicate eye area.
Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily. Pat dry.
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, Disodium Laureth Sulfosuccinate, Cocamidopropyl Hydroxysultaine (Coconut Derived), Cocamidopropylamine Oxide, PEG-150 Distearate, Polysorbate 20, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Glycerin (Vegetable Derived), Lavandula Angustifolia (Lavender) Oil, Aniba Rosodora (Rosewood) Wood Oil, Salix Alba (Willow) Bark Extract, Organic Chamomilla Recutita (Matricaria) Flower Extract1, Decyl Glucoside (Plant Derived), Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin.

1: Certified Organic Ingredients

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

PRINCIPAL DISPLAY PANEL - 175 mL Bottle Label

ANTI-ACNE

100% VEGAN • GMO-FREE
ECO-ETHICAL
CRUELTY-FREE

DERMA•E

Acne Deep Pore
Cleansing Wash

Active Salicylic Acid
with Tea Tree Oil + Chamomile

6 FL OZ / 175 mL

PRINCIPAL DISPLAY PANEL - 175 mL Bottle Label

ACNE DEEP PORE CLEANSING WASH
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54108-3700
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TEA TREE OIL (UNII: VIF565UC2G)
GLYCERIN (UNII: PDC6A3C0OX)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ROSEWOOD OIL (UNII: F2522O5L7B)
SALIX ALBA BARK (UNII: 205MXS71H7)
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54108-3700-1	175 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M006	01/01/2015

Labeler - derma e (148940450)

Name	Address	ID/FEI	Business Operations
Establishment
Topiderm, Inc.		049121643	MANUFACTURE(54108-3700)

Name	Address	ID/FEI	Business Operations
Establishment
Topix Pharmaceuticals, Inc.		117745066	PACK(54108-3700)

Acne Deep Pore Cleansing Wash