Label: DERMAHARMONY 5% BENZOYL PEROXIDE CLEANSING BAR- benzoyl peroxide soap
- NDC Code(s): 71819-013-04
- Packager: D3 Development, 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.
Updated July 29, 2021
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
For external use only
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.
DOSAGE & ADMINISTRATION
- 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
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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 final part333D 07/29/2021 Labeler - D3 Development, Inc. (043195877)