BREAKOUT CLEARING OVERNIGHT TREATMENT- salicylic acid lotion

Breakout Clearing Overnight Treatment by

Drug Labeling and Warnings

Breakout Clearing Overnight Treatment by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., Cosway, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid (2.0%).

Indications

• for the treatment of acne

Warnings

For external use only.

Do not use

• in or near eyes. If contact occurs, flush thoroughly with water

When using this product

• apply to affected areas only
• 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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean the skin thoroughly before applying.
• Cover the affected area with a thin layer at night.
• Because too much drying of the skin may occur, start with 1 application daily at night, and if bothersome dryness or peeling occurs, reduce application to 2 to 3 times per week.

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Water/Aqua/Eau, Isohexadecane, PEG-32, Glyceryl Stearate, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Alcohol, Butylene Glycol, C12-15 Alkyl Benzoate, Stearic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Spiraea Ulmaria Extract, Camphor, Lavandula Angustifolia (Lavender) Flower Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra Rhizome/Root, Porphyra Umbilicalis Extract, Cucumis Sativus (Cucumber) Fruit Extract, Sodium Hyaluronate Crosspolymer, Caprylic/ Capric Triglyceride, Zinc Acetate, Potassium Jojobate, Propanediol, PVM/ MA Copolymer, Ceteareth-20, Xanthan Gum, Polysorbate 60, Jojoba Alcohol, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

Questions or comments

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton

dermalogica®
clear

2%
salicylic
acid

Breakout Clearing
Overnight
Treatment

2.0 US FL OZ / 59 mL e

INGREDIENTS AND APPEARANCE

BREAKOUT CLEARING OVERNIGHT TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-313
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)
Isohexadecane (UNII: 918X1OUF1E)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Dimethicone (UNII: 92RU3N3Y1O)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Butylene Glycol (UNII: 3XUS85K0RA)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Stearic Acid (UNII: 4ELV7Z65AP)
Tea Tree Oil (UNII: VIF565UC2G)
FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
Lavandula Angustifolia Flower (UNII: 19AH1RAF4M)
Green Tea Leaf (UNII: W2ZU1RY8B0)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
Porphyra Umbilicalis (UNII: 14AN0J70WO)
Cucumber (UNII: YY7C30VXJT)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Zinc Acetate (UNII: FM5526K07A)
Propanediol (UNII: 5965N8W85T)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Xanthan Gum (UNII: TTV12P4NEE)
Polysorbate 60 (UNII: CAL22UVI4M)
Sodium Hydroxide (UNII: 55X04QC32I)
Ethylhexylglycerin (UNII: 147D247K3P)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-313-02	1 in 1 CARTON
1		59 mL in 1 TUBE
2	NDC: 68479-313-01	14 mL in 1 TUBE
3	NDC: 68479-313-00	2 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	09/06/2013

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway		620899877	MANUFACTURE(68479-313)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-313)