ACNE SPOT TREATMENT- salicylic acid gel

Acne Spot Treatment by

Drug Labeling and Warnings

Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by DERMA E. 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

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, Hydroxypropyl Starch Phosphate (Sugar Starch), Glycerin (Vegetable Derived), Hamamelis Virginiana (Witch Hazel) Extract, Decyl Glucoside (Plant Derived), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Salix Alba (Willow) Bark Extract, Aniba Rosodora (Rosewood) Wood Oil, Lavandula Angustifolia (Lavender) Oil, Organic Aloe Barbadensis (Aloe Vera) Extract 1, Organic Chamomilla Recutita (Matricaria) Flower Extract 1, Allantoin, Panthenol (Provitamin B5), Glyceryl Stearate (Vegetable Derived), Glyceryl Stearate Citrate (Vegetable Derived), Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin.

1 Certified Organic Ingredients

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-933-9344

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

ANTI-ACNE

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

DERMAE

Acne Spot
Treatment

Active Salicylic Acid
with Tea Tree Oil
+ Aloe Vera

1/2 OZ / 14 g

INGREDIENTS AND APPEARANCE

ACNE SPOT TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-3800
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
GLYCERIN (UNII: PDC6A3C0OX)
TEA TREE OIL (UNII: VIF565UC2G)
SALIX ALBA BARK (UNII: 205MXS71H7)
ROSEWOOD OIL (UNII: F2522O5L7B)
PANTHENOL (UNII: WV9CM0O67Z)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54108-3800-1	1 in 1 CARTON	01/01/2015
1		14 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 final	part333D	01/01/2015

Labeler - DERMA E (148940450)