Label: BENZOAZELINE FORTE- benzoyl peroxide cream
- NDC Code(s): 78863-1180-2
- Packager: Noon Aesthetics M.R. Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 23, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- INDICATIONS & USAGE
-
Warnings
For external use only.
When using 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 at a time.
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 the eyes, lips, and mouth, avoid contact with hair and dyed fabrics, which may be bleached by this product, 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
-
Directions
Cleanse the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
If bothersome dryness of peeling occurs, reduce application to one a day or every other day. If irritation or sensitivity develops, stop use of both products and ask a doctor.
If going outside, apply sunscreen after using this product.
-
Inactive Ingredients
Water, Azelaic Acid, Strontium Nitrate, Potassium Azeloyl Diglycinate, Isononyl Isononanoate, Cyclopentasiloxane, Glycerin, Propanediol, Ethoxydiglycol, Dimethyl Sulfone, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 20, Cetyl Palmitate, Phenoxyethanol, Dimethicone, Arachidyl Alcohol, Cetyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Caprylyl Glycol, Sodium phytate, Glucose, Alcohol
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 gr Tube Carton
-
INGREDIENTS AND APPEARANCE
BENZOAZELINE FORTE
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78863-1180 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 0.2 g in 50 g Inactive Ingredients Ingredient Name Strength Azelaic Acid (UNII: F2VW3D43YT) Water (UNII: 059QF0KO0R) Strontium Nitrate (UNII: BDG873AQZL) Potassium Azeloyl Diglycinate (UNII: N02RVN6NYP) Isononyl Isononanoate (UNII: S4V5BS6GCX) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) Glycerin (UNII: PDC6A3C0OX) Propanediol (UNII: 5965N8W85T) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) Polysorbate 20 (UNII: 7T1F30V5YH) CETYL PALMITATE (UNII: 5ZA2S6B08X) Phenoxyethanol (UNII: HIE492ZZ3T) Dimethicone (UNII: 92RU3N3Y1O) Arachidyl Alcohol (UNII: 1QR1QRA9BU) Cetyl Alcohol (UNII: 936JST6JCN) DOCOSANOL (UNII: 9G1OE216XY) Arachidyl Glucoside (UNII: 6JVW35JOOJ) Caprylyl Glycol (UNII: 00YIU5438U) PHYTATE SODIUM (UNII: 88496G1ERL) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78863-1180-2 1 in 1 CARTON 01/09/2022 1 50 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M006 01/09/2022 Labeler - Noon Aesthetics M.R. Ltd (600185560) Establishment Name Address ID/FEI Business Operations NOON Aesthetics M.R Ltd 600185560 MANUFACTURE(78863-1180)
