BREAKOUT CLEARING DAYTIME TREATMENT- benzoyl peroxide lotion

Breakout Clearing Daytime Treatment by

Drug Labeling and Warnings

Breakout Clearing Daytime Treatment by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., PakLab, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzoyl Peroxide (2.5%).

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

When using this product

• apply to affected areas only
• avoid unnecessary sun exposure and use sunscreen
• This product may bleach hair or dyed fabrics.
• Using other topical acne products at the same time or immediately following the use of this product may increase dryness or irritation of the skin. Only one product should be used unless directed by a physican.

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 Daytime Treatment to dry then follow directions of the sunscreen labeling.

Inactive ingredients

Water/Aqua/Eau, Niacinamide, Glycerin, Dimethicone, Helianthus Annuus (Sunflower) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Lavandula Angustifolia (Lavender) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Boerhavia Diffusa Root Extract, Sodium Acrylates Copolymer, Lecithin, Galactoarabinan, Glyceryl Polyacrylate, Polyisobutene, Dipotassium Glycyrrhizate, Butylene Glycol, Xanthan Gum, Polyacrylate-13, 1,2-Hexanediol, Polysorbate 20, Disodium EDTA, Citric Acid, 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 - 60 mL Tube Carton

dermalogica®
clear

2.5%
benzoyl
peroxide

Breakout Clearing
Daytime
Treatment

2.0 US Fl. Oz. / 60 mL e

INGREDIENTS AND APPEARANCE

BREAKOUT CLEARING DAYTIME TREATMENT 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Niacinamide (UNII: 25X51I8RD4)
Glycerin (UNII: PDC6A3C0OX)
Dimethicone (UNII: 92RU3N3Y1O)
Sunflower Oil (UNII: 3W1JG795YI)
Cucumber (UNII: YY7C30VXJT)
Lavandula Angustifolia Flowering Top (UNII: 9YT4B71U8P)
Rosemary (UNII: IJ67X351P9)
Boerhavia Diffusa Root (UNII: KR0SR09KYL)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Egg Phospholipids (UNII: 1Z74184RGV)
Galactoarabinan (UNII: SL4SX1O487)
Polyisobutylene (1300 MW) (UNII: 241BN7J12Y)
Butylene Glycol (UNII: 3XUS85K0RA)
Xanthan Gum (UNII: TTV12P4NEE)
1,2-Hexanediol (UNII: TR046Y3K1G)
Polysorbate 20 (UNII: 7T1F30V5YH)
Edetate Disodium (UNII: 7FLD91C86K)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-160-02	1 in 1 CARTON
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-160-01	14 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68479-160-00	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	part333D	06/04/2013

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	MANUFACTURE(68479-160)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-160)