BREAKOUT CLEARING ALL OVER TONER- salicylic acid liquid

Breakout Clearing All Over Toner by

Drug Labeling and Warnings

Breakout Clearing All Over Toner 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 (1.0%)

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

• Apply to cleansed face and throat twice daily.
• Keep eyes closed.

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Water/Aqua/Eau, Hamamelis Virginiana (Witch Hazel) Water, Isoceteth-20, Ethoxydiglycol, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Camellia Sinensis Leaf Extract, Porphyra Umbilicalis Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Citrus Aurantium Amara (Bitter Orange) Peel Oil, Citrus Limon (Lemon) Fruit Oil, Cymbopogon Schoenanthus Oil, Argania Spinosa Kernel Extract, Serenoa Serrulata Fruit Extract, Sesamum Indicum (Sesame) Seed Extract, Citral, Hexylene Glycol, Geraniol, Limonene, Polysorbate 20, Disodium EDTA, Butylene Glycol, Linalool, Ethylhexylglycerin, Phenoxyethanol.

Questions or comments

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

dermalogica®
clear

1%
salicylic
acid

Breakout Clearing
All Over
Toner

4.0 US FL OZ / 118 mL e

INGREDIENTS AND APPEARANCE

BREAKOUT CLEARING ALL OVER TONER 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-312
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Hamamelis Virginiana Top Water (UNII: NT00Y05A2V)
Isoceteth-20 (UNII: O020065R7Z)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Hexylene Glycol (UNII: KEH0A3F75J)
Orange Oil (UNII: AKN3KSD11B)
Lavender Oil (UNII: ZBP1YXW0H8)
Sodium Hydroxide (UNII: 55X04QC32I)
Tea Tree Oil (UNII: VIF565UC2G)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Porphyra Umbilicalis (UNII: 14AN0J70WO)
.Beta.-Sitosterol (UNII: S347WMO6M4)
Glycyrrhiza Glabra (UNII: 2788Z9758H)
Bitter Orange Oil (UNII: 9TLV70SV6I)
Citrus Limon Fruit Oil (UNII: 0HNC1J1YED)
Cymbopogon Schoenanthus Oil (UNII: XE7K568ILO)
Argania Spinosa Seed (UNII: 8H7X7XB54H)
Saw Palmetto (UNII: J7WWH9M8QS)
Sesame Seed (UNII: 7Y1255HVXR)
Polysorbate 20 (UNII: 7T1F30V5YH)
Edetate Disodium (UNII: 7FLD91C86K)
Butylene Glycol (UNII: 3XUS85K0RA)
Ethylhexylglycerin (UNII: 147D247K3P)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-312-02	1 in 1 CARTON
1		118 mL in 1 BOTTLE
2	NDC: 68479-312-01	50 mL in 1 BOTTLE
3	NDC: 68479-312-00	2 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	09/05/2013

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway		620899877	MANUFACTURE(68479-312)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-312)