BREAKOUT CLEARING DAYTIME TREATMENT- 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 Daytime Treatment

Drug Facts

Active ingredient

Benzoyl Peroxide (2.5%).

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

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

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

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

Principal Display Panel - 60 mL Tube Carton
BREAKOUT CLEARING DAYTIME TREATMENT 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-160-021 in 1 CARTON
160 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68479-160-0114 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:68479-160-002 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D06/04/2013
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
PakLab790530976MANUFACTURE(68479-160)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-160)

Revised: 11/2015
Document Id: d00ecad9-7ca8-4d61-a84b-3894c8f9a99e
Set id: 836ca02b-098d-456e-9a88-bdaf69656cab
Version: 2
Effective Time: 20151124
 
Dermalogica, Inc.