Label: MONAT ACNE TREATMENT- benzoyl peroxide cream
- NDC Code(s): 78518-295-01
- Packager: Monat Global Corp
- 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.
Drug Label Information
Updated March 21, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
-
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 creamProduct 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)