BREAKOUT CLEARING EMERGENCY SPOT FIX- benzoyl peroxide lotion 
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 Emergency Spot Fix

Drug Facts

Active ingredient

Benzoyl Peroxide (5.0%)

Purpose

Acne Treatment

Use

Warnings

For external use only

Do not use

  • In or near eyes
  • On broken skin
  • On lips or large areas of the body
  • If you have very sensitive skin
  • If you are sensitive to benzoyl peroxide

Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

When using this product

  • Apply to affected areas only.
  • Avoid unnecessary sun exposure and use sunscreen.
  • This product may bleach hair or dyed fabrics.
  • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time.

Stop use and ask a physician

  • If too much skin irritation or sensitivity develops or increases.

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, PEG-8, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Porphyra Umbilicalis Extract, Enantia Chlorantha Bark Extract, Oleanolic Acid, Lavandula Angustifolia (Lavender) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Spiraea Ulmaria Extract, Cetyl Alcohol, Sodium Acrylate/Sodium Acryloyl Dimethyl Taurate Copolymer, Polysorbate 80, Glyceryl Stearate, Caprylic/Capric Triglyceride, Ethylhexylglycerin, Butylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Xanthan Gum, Disodium EDTA, Phenoxyethanol.

Questions or comments

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

PRINCIPAL DISPLAY PANEL - 9 mL Tube Carton

dermalogica®
clear

5%
benzoyl
peroxide

Breakout Clearing
Emergency
Spot Fix

0.3 US FL OZ / 9 mL e

Principal Display Panel - 9 mL Tube Carton
BREAKOUT CLEARING EMERGENCY SPOT FIX 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Glycyrrhiza Glabra (UNII: 2788Z9758H)  
Porphyra Umbilicalis (UNII: 14AN0J70WO)  
Annickia Chlorantha Bark (UNII: H70115MP4A)  
Oleanolic Acid (UNII: 6SMK8R7TGJ)  
Lavandula Angustifolia Flowering Top (UNII: 9YT4B71U8P)  
Tea Tree Oil (UNII: VIF565UC2G)  
Filipendula Ulmaria Root (UNII: 997724QNDS)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW) (UNII: 1DXE3F3OZX)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
Aminomethylpropanol (UNII: LU49E6626Q)  
Xanthan Gum (UNII: TTV12P4NEE)  
Edetate Disodium (UNII: 7FLD91C86K)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-202-021 in 1 CARTON
19 mL in 1 TUBE
2NDC:68479-202-002 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D06/03/2013
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
Cosway620899877MANUFACTURE(68479-202)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-202)

Revised: 2/2014
Document Id: a428575c-cefa-4f1d-8712-faf36371ae8c
Set id: f1db1790-822e-41b3-af4d-1e28387c090d
Version: 1
Effective Time: 20140205
 
Dermalogica, Inc.