Label: MODESA ACNE TREATMENT- benzoyl peroxide cream

  • NDC Code(s): 55621-017-01
  • Packager: Zhejiang Jingwei Pharmaceutic Al Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients

    Benzoyl peroxide  10%

  • PURPOSE

    Purpose

    Acne medication

  • INDICATIONS & USAGE

      for the treatment and prevention of acne pimples Uses

  • WARNINGS

    Warnings

    •For external use only

    Do not use

    •if you have sensitive skin or are sensitive to benzoyl peroxide

    When using this product

    •avoid contact with eyes, lips and mouth •avoid contact

    with hair or dyed fabrics including carpet and clothing which

    may be bleached by this product  •with other topical acne

    medicaitons, at the same time nor immediately following use

    of this product, increased dryness or irritation of the skin

    may occur. If this occurs, only one medicaiton should be used

    unless directed by a doctor  •skin irritaiton may occur,

    characterized by redness, burning, itching, peeling or possibly

    swelling. More frequent use or higher concentration may

    aggravtae skin irritation. Mild irritation may be reduced by

    using the product less frequently or in a lower concentration

    •avoid unnecessary sun exposure and use a sunscreen

    Stop use and ask a doctor

    •if skin irritation becomes severe

  • KEEP OUT OF REACH OF CHILDREN

      In case of accidental ingestion, Keep out of reach of children.

    get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    •cleanse the skin thoroughly before applying medication

    •cover the entire affected area with a thin layer one to three

    times a day

    •because excessive drying of the skin may occur, start with

    one applicaiton daily, then gradually increase to two to 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

  • STORAGE AND HANDLING

      •keep tightly closed Other information

    •store at room temperature 68° - 86° F (20° - 30°C).

  • INACTIVE INGREDIENT

      aluminum hydroxide, bentonite, Inactive ingredients

    carbomer, glycerin monostearate, isopropyl myristate,

    methylparaben, peg-12, potassium hydroxide, propylene glycol,

    propylparaben, water

  • QUESTIONS

      1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MODESA   ACNE TREATMENT
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DIGLYCERIN MONOSTEARATE (UNII: E3XK1VOF1Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55621-017-011 in 1 CARTON08/20/2017
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00608/20/2017
    Labeler - Zhejiang Jingwei Pharmaceutic Al Co., Ltd. (530876549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Jingwei Pharmaceutic Al Co., Ltd.530876549manufacture(55621-017)