BREAKOUT CLEARING FOAMING WASH- salicylic acid liquid

Breakout Clearing Foaming Wash by

Drug Labeling and Warnings

Breakout Clearing Foaming Wash by is a Otc medication manufactured, distributed, or labeled by Dermalogica, McKenna. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid (0.5%).

Purpose

Acne Treatment.

Use

• for the treatment of acne

Warnings

For external use only

Do not use

• around eye area. If contact occurs, flush thoroughly with water.
• If irritation develops, discontinue use.

When using this product

• If dryness or irritation occurs when using other topical acne products at the same time, limit usage to one topical acne product.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Work a pea-sized amount into a lather in wet hands.
• Apply to dampened face and throat, massaging in circular motions while concentrating on areas of congestion and oiliness.
• Avoid eye area.
• Rinse thoroughly with warm water.

Inactive ingredients

Water/Aqua/Eau, Cocamidopropyl Betaine, Sodium Lauroyl Methyl Isethionate, Acrylates/Beheneth-25 Methacrylate Copolymer, Polysorbate-20, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Oleanolic Acid, Butylene Glycol, Enantia Chlorantha Bark Extract, Disodium Cocoamphodiacetate, Spiraea Ulmaria Extract, Camellia Sinensis Leaf Extract, Porpyra Umbilicalis Extract, Glycyrrhiza Glabra (Licorice) Rhizome/Root Extract, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

Other information

• Protect this product from excessive heat and direct sun.

Questions or comments

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

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton

dermalogica®
clear

0.5%

salicylic
acid

Breakout Clearing

Foaming
Wash

6.0 US Fl. Oz. / 177 mL e

INGREDIENTS AND APPEARANCE

BREAKOUT CLEARING FOAMING WASH 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TEA TREE OIL (UNII: VIF565UC2G)
ORANGE OIL (UNII: AKN3KSD11B)
LAVENDER OIL (UNII: ZBP1YXW0H8)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-101-02	1 in 1 CARTON
1		177 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68479-101-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 68479-101-00	2 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	05/13/2013

Labeler - Dermalogica (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	MANUFACTURE(68479-101)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-101)