BREAKOUT CLEARING ALL OVER TONER- salicylic acid liquid 
Dermalogica, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Breakout Clearing All Over Toner

Drug Facts

Active ingredient

Salicylic Acid (1.0%)

Purpose

Acne Treatment

Use

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

Other information

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

Principal Display Panel - 118 mL Bottle Carton
BREAKOUT CLEARING ALL OVER TONER 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-312-021 in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:68479-312-0150 mL in 1 BOTTLE
3NDC:68479-312-002 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H09/05/2013
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
Cosway620899877MANUFACTURE(68479-312)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-312)

Revised: 2/2014
Document Id: dae6a0bd-aebb-45af-bc39-07db70052c10
Set id: 66722610-4b32-466e-b7bf-caee04c92910
Version: 1
Effective Time: 20140205
 
Dermalogica, Inc.