BREAKOUT CLEARING EMERGENCY SPOT FIX- benzoyl peroxide lotion

Breakout Clearing Emergency Spot Fix by

Drug Labeling and Warnings

Breakout Clearing Emergency Spot Fix 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

Benzoyl Peroxide (5.0%)

Purpose

Acne Treatment

Use

• For the treatment of acne

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

• Cleanse the skin thoroughly before applying.
• Cover the affected area with a thin layer 1 to 3 times a day.
• Because too much drying of the skin may occur, start with one application daily, and then gradually increase to 2 or 3 times daily if needed or as directed by a physician.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• If going outside, use a sunscreen. Allow Emergency Spot Fix to dry, then follow directions of the sunscreen labeling.
• If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

• Protect this product from excessive heat and direct sun.

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

INGREDIENTS AND APPEARANCE

BREAKOUT CLEARING EMERGENCY SPOT FIX 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-202-02	1 in 1 CARTON
1		9 mL in 1 TUBE
2	NDC: 68479-202-00	2 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	06/03/2013

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway		620899877	MANUFACTURE(68479-202)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-202)