DERMAHARMONY 10% BENZOYL PEROXIDE CLEANSING BAR- benzoyl peroxide soap 
D3 Development, 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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Dermaharmony 10% Benzoyl Peroxide Bar

Drug Facts

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Use

for the management of acne

Warnings

For external use only

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • 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.

Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Store in a dry place between 59-86°F (15-30°C)

Inactive ingredients

Sodium cocoyl isethionate, stearic acid, coconut fatty acid, sodium isethionate, water. coco glucoside, cetearyl alcohol & ceteareth-20, lactic acid

Questions?

1-800-827-3730

www.dermaharmony.com

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in USA of U.S. and imported ingredients.

NDC Code: 71819-011-04

dermaharmony

10% Benzoyl Peroxide

Cleansing Bar

FOR THE TREATMENT OF ACNE

Reduces: pimples-blemishes-whiteheads-blackheads

NET WT 4 OZ (113G)

BPO=V1 Final

DERMAHARMONY 10% BENZOYL PEROXIDE  CLEANSING BAR
benzoyl peroxide soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
LACTIC ACID (UNII: 33X04XA5AT)  
COCO GLUCOSIDE (UNII: ICS790225B)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
COCONUT ACID (UNII: 40U37V505D)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM ISETHIONATE (UNII: 3R36J71C17)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71819-011-04113 g in 1 CARTON; Type 0: Not a Combination Product07/13/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/13/2021
Labeler - D3 Development, Inc. (043195877)

Revised: 7/2021
Document Id: c7083b69-fed3-d497-e053-2a95a90a1a8c
Set id: c7083b69-fed4-d497-e053-2a95a90a1a8c
Version: 1
Effective Time: 20210713
 
D3 Development, Inc.