DERMAHARMONY 5% BENZOYL PEROXIDE CLEANSING BAR- benzoyl peroxide soap

Dermaharmony 5% Benzoyl Peroxide by

Drug Labeling and Warnings

Dermaharmony 5% Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by D3 Development, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Benzoyl peroxide 5%

PURPOSE

Purpose

Acne medication

INDICATIONS & USAGE

Use

for the management of acne

WARNINGS

Warnings

For external use only

Do not useif 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 ifirritation becomes severe.

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

DOSAGE & ADMINISTRATION

Directions

• using warm water, wash affected area for 1-2 minutes
• rinse thoroughly and pat dry with a clean towel
• start with 1 application daily, then gradually increase to 2-3 times daily if needed or as directed by a doctor
• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

Sodium cocoyl isethionate, stearic acid, coconut fatty acid, sodium isethionate, water. coco glucoside, cetearyl alcohol & ceteareth-20, iron oxides (red and yellow), lactic acid

QUESTIONS

Questions?

1-800-827-3730

www.dermaharmony.com

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

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

NDC Code: 71819-013-04

PRINCIPAL DISPLAY PANEL

dermaharmony

5% Benzoyl Peroxide

Cleansing Bar

FOR THE TREATMENT OF ACNE

Reduces: pimples-blemishes-whiteheads-blackheads

NET WT 4 OZ (113G)

INGREDIENTS AND APPEARANCE

DERMAHARMONY 5% BENZOYL PEROXIDE  CLEANSING BAR
benzoyl peroxide soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71819-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71819-013-04	113 g in 1 CARTON; Type 0: Not a Combination Product	07/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	07/29/2021

Labeler - D3 Development, Inc. (043195877)

Establishment
Name	Address	ID/FEI	Business Operations
Vanguard Soap, LLC.		831404954	manufacture(71819-013)