ACNE DEEP PORE CLEANSING WASH- salicylic acid gel

Acne Deep Pore Cleansing Wash by

Drug Labeling and Warnings

Acne Deep Pore Cleansing Wash 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]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

DERMAE

Acne Deep Pore
Cleansing Wash

Active Salicylic Acid
with Tea Tree Oil + Chamomile

6 FL OZ / 175 mL

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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 (UNII: G0R4UBI2ZZ)
Decyl Glucoside (UNII: Z17H97EA6Y)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/01/2015

Labeler - DERMA E (148940450)