MONAT ACNE TREATMENT- benzoyl peroxide cream 
Monat Global Corp

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.

----------

Benzoyl Peroxide 5%

Acne Treatment

For the treatment of acne.

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

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.

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.

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

Carton

MONAT ACNE TREATMENT 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78518-295
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78518-295-0115 mL in 1 TUBE; Type 0: Not a Combination Product03/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/21/2023
Labeler - Monat Global Corp (027036949)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(78518-295)

Revised: 3/2023
Document Id: f76eb53e-643e-52cf-e053-6394a90a6e8f
Set id: f76eb53e-643d-52cf-e053-6394a90a6e8f
Version: 1
Effective Time: 20230321
 
Monat Global Corp