Otc - Active Ingredient
Active ingredients
Benzoyl peroxide 10%
Modesa Cream
FDA Label NDC 55621-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Jingwei Pharmaceutic Al Co., Ltd. for the product Modesa (NDC 55621-017). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Acne medication
Indications & Usage
Uses for the treatment and prevention of acne pimples
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion,
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
Other information •keep tightly closed
•store at room temperature 68° - 86° F (20° - 30°C).
Inactive Ingredient
Inactive ingredients aluminum hydroxide, bentonite,
carbomer, glycerin monostearate, isopropyl myristate,
methylparaben, peg-12, potassium hydroxide, propylene glycol,
propylparaben, water
Otc - Questions
Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST
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