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Breakout Clearing Daytime Treatment

Dosage form: lotion
Ingredients: Benzoyl Peroxide 25mg in 1mL
Labeler: Dermalogica, Inc.
NDC Code: 68479-160

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.

Breakout Clearing Daytime Treatment

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

BREAKOUT CLEARING DAYTIME TREATMENT 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-160
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Niacinamide 
Glycerin 
Dimethicone 
Sunflower Oil 
Cucumber 
Lavandula Angustifolia Flowering Top 
Rosemary 
Boerhavia Diffusa Root 
Glycyrrhizinate Dipotassium 
Egg Phospholipids 
Galactoarabinan 
Polyisobutylene (1300 MW) 
Butylene Glycol 
Xanthan Gum 
1,2-Hexanediol 
Polysorbate 20 
Edetate Disodium 
Citric Acid Monohydrate 
Phenoxyethanol 
Ethylhexylglycerin 
Packaging
#Item CodePackage Description
1NDC:68479-160-021 TUBE in 1 CARTON
160 mL in 1 TUBE
2NDC:68479-160-0114 mL in 1 TUBE
3NDC:68479-160-002 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D06/04/2013
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIOperations
PakLab790530976MANUFACTURE(68479-160)
Establishment
NameAddressID/FEIOperations
Diamond Wipes161104729MANUFACTURE(68479-160)

Revised: 11/2015
 
Dermalogica, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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