Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

For the treatment of acne

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

Apply a small amount to wet skin.
Cover the entire affected area with a thin layer, gently massage in circular motion. Rinse thoroughly with warm water and 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, Cetyl Alcohol (Plant Derived), Prunus Armeniaca (Apricot) Seed Powder, Stearic Acid (Vegetable Derived), Glyceryl Stearate Citrate (Vegetable Derived), Hydroxypropyl Starch Phosphate (Sugar Starch), Caprylic/Capric Triglyceride (Vegetable Derived), Glycerin (Vegetable Derived), Decyl Glucoside (Plant Derived), Xanthan Gum, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Aniba Rosodora (Rosewood) Wood Oil, Salix Alba (Willow) Bark Extract, Allantoin, Organic Aloe Barbadensis (Aloe Vera) Extract1, Organic Simmondsia Chinensis (Jojoba) Seed Oil1, Organic Chamomilla Recutita (Matricaria) Flower Extract1, Polysorbate 60, Polysorbate 20, Glyceryl Stearate SE, Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin.

1: Certified Organic Ingredients

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

ANTI-ACNE

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

DERMA•E

Deep Pore
Acne Scrub

Active Salicylic Acid
with Tea Tree Oil + Aloe Vera

4 OZ / 113 g

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

DEEP PORE ACNE SCRUB
salicylic acid paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54108-3750
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 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PRUNUS ARMENIACA SEED (UNII: 75356789IW)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
TEA TREE OIL (UNII: VIF565UC2G)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALLANTOIN (UNII: 344S277G0Z)
SALIX ALBA BARK (UNII: 205MXS71H7)
ROSEWOOD OIL (UNII: F2522O5L7B)
JOJOBA OIL (UNII: 724GKU717M)
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54108-3750-1	113 g in 1 TUBE; 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)

Registrant - Topiderm, Inc. (049121643)

Name	Address	ID/FEI	Business Operations
Establishment
Topiderm, Inc.		049121643	MANUFACTURE(54108-3750)

Deep Pore Acne Scrub