DailyMed - BREAKOUT CLEARING DAYTIME TREATMENT- benzoyl peroxide lotion

Contains inactivated NDC Code(s)
NDC Code(s): 68479-160-00, 68479-160-01, 68479-160-02
Packager: Dermalogica, Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 24, 2015

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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Active ingredient
Benzoyl Peroxide (2.5%).

Benzoyl Peroxide (2.5%).
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Purpose
Acne Treatment.

Acne Treatment.
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Use
for the treatment of acne
- for the treatment of acne
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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 ...
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.

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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 ...
- 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.
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Inactive ingredients
Water/Aqua/Eau, Niacinamide, Glycerin, Dimethicone, Helianthus Annuus (Sunflower) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Lavandula Angustifolia (Lavender) Flower Extract, Rosmarinus ...

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.
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Other information
Protect this product from excessive heat and direct sun.
- Protect this product from excessive heat and direct sun.
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Questions or comments
Call toll free 1-800-831-5150 in the US

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

dermalogica®
clear

2.5%
benzoyl
peroxide

Breakout Clearing
Daytime
Treatment

2.0 US Fl. Oz. / 60 mL e

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INGREDIENTS AND APPEARANCE

Product Information

BREAKOUT CLEARING DAYTIME TREATMENT benzoyl peroxide lotion

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	06/04/2013

Labeler - Dermalogica, Inc. (177698560)

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

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

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Published Date (What is this?)	Version	Files
Nov 25, 2015	2 (current)	download
Feb 18, 2014	1	download

	RxCUI	RxNorm NAME	RxTTY
1	200009	benzoyl peroxide 2.5 % Topical Lotion	PSN
2	200009	benzoyl peroxide 25 MG/ML Topical Lotion	SCD
3	200009	benzoyl peroxide 2.5 % Topical Lotion	SY

	NDC
1	68479-160-00 (inactivated)
2	68479-160-01 (inactivated)
3	68479-160-02 (inactivated)

Label: BREAKOUT CLEARING DAYTIME TREATMENT- benzoyl peroxide lotion

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Do not use

When using this product

Stop use and ask a physician

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Label: BREAKOUT CLEARING DAYTIME TREATMENT- benzoyl peroxide lotion

View Package Photos

Drug Label Info

Safety

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Drug Label Information

Do not use

When using this product

Stop use and ask a physician

Find additional resources

Safety

Related Resources

More Info on this Drug

BREAKOUT CLEARING DAYTIME TREATMENT- benzoyl peroxide lotion

Number of versions: 2

BREAKOUT CLEARING DAYTIME TREATMENT- benzoyl peroxide lotion

BREAKOUT CLEARING DAYTIME TREATMENT- benzoyl peroxide lotion

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BREAKOUT CLEARING DAYTIME TREATMENT- benzoyl peroxide lotion

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.