MONAT ACNE TREATMENT- benzoyl peroxide cream

Monat Acne Treatment by

Drug Labeling and Warnings

Monat Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Monat Global Corp, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzoyl Peroxide 5%

PURPOSE

Acne Treatment

INDICATIONS & USAGE

For the treatment of acne.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Clean skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, 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 or peeling occurs, reduce application to once a day or every other day. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

INACTIVE INGREDIENT

Water, Isostearyl Alcohol, Glycerin, Pentylene Glycol, Silica, Hamamelis Virginiana (Witch Hazel) Water, Epilobium Angustifolium Flower/Leaf/Stem Extract, Phragmites Communis Extract, Poria Cocos Extract, Niacinamide, Tocopheryl Acetate, Carbomer, Potassium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA.

WARNINGS

For external use only. Do not use if you have very sensitive skin or are sensitive to benzoyl peroxide. 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 treatment at a time, avoid unnecessary sun exposure and use sunscreen, avoid contact with 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 consult with a doctor if irritation becomes severe.

Package Label

INGREDIENTS AND APPEARANCE

MONAT ACNE TREATMENT 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78518-295
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 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
NIACINAMIDE (UNII: 25X51I8RD4)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FU LING (UNII: XH37TWY5O4)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHRAGMITES AUSTRALIS STEM (UNII: 3AW23L82V4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78518-295-01	15 mL in 1 TUBE; Type 0: Not a Combination Product	03/21/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/21/2023

Labeler - Monat Global Corp (027036949)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(78518-295)