BENZOAZELINE FORTE- benzoyl peroxide cream

Benzoazeline Forte by

Drug Labeling and Warnings

Benzoazeline Forte by is a Otc medication manufactured, distributed, or labeled by Noon Aesthetics M.R. Ltd, NOON Aesthetics M.R Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Benzoyl Peroxide 10%

Purpose

Acne treatment

INDICATIONS & USAGE

Use for the treatment of acne

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

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

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

Protect this product form excessive heat and direct sun.

Questions or comments?

Visit www.noonaesthetics.com
Or call Toll Free 1-833-666-6246

PRINCIPAL DISPLAY PANEL - 50 gr Tube Carton

NOON ™

BenzoAzelin
Forte
with DermShield ™

Treatment for Acne,
Bumpy Skin with
Papules and Associated
Redness (Rose-Red
Papules / Red Rash)

Azelaic Acid 13%
Azeloglicina 10%
Benzoyl Peroxide 10%

PARACEUTICAL

50 gr / 1.76 Oz e

INGREDIENTS AND APPEARANCE

BENZOAZELINE FORTE 
benzoyl peroxide cream

Product 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)