Modesa

Manufacturer
Zhejiang Jingwei Pharmaceutic Al Co., Ltd.
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:07

Label at a glance#

ProductModesa Acne Treatment
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Storage and handling

  •keep tightly closed Other information •store at room temperature 68° - 86° F (20° - 30°C).

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Benzoyl peroxide  10%

OTC - PURPOSE SECTION

Purpose

Acne medication

INDICATIONS & USAGE SECTION

  for the treatment and prevention of acne pimples Uses

WARNINGS SECTION

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 SECTION

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

get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

  •keep tightly closed Other information

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

INACTIVE INGREDIENT SECTION

  aluminum hydroxide, bentonite, Inactive ingredients

carbomer, glycerin monostearate, isopropyl myristate,

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

propylparaben, water

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106315benzoyl peroxide 10 % Topical CreamPSN2
106315benzoyl peroxide 100 MG/ML Topical CreamSCD2
106315benzoyl peroxide 10 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55621-017-01Modesa Acne Treatment1 in 1 CARTONCREAM12
55621-017-01Modesa Acne Treatment28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-017MODESA ACNE TREATMENT (BENZOYL PEROXIDE) CREAM [ZHEJIANG JINGWEI PHARMACEUTIC AL CO., LTD.]2Current NDC, Legacy NDC, 2 package rows20231027_dbfe8b9e-e343-4ed5-bd81-01b27b4aa912.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55621-01755621-017-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Modesa Acne TreatmentBENZOYL PEROXIDEZhejiang Jingwei Pharmaceutic Al Co., Ltd.dbfe8b9e-e343-4ed5-bd81-01b27b4aa9122023-10-27WarningsExact identifier
ndc (package): 55621-017-01
ndc (product): 55621-017
ndc11 (package): 55621001701
spl id: 08ad180e-e886-ba6f-e063-6394a90a2bc7
spl set id: dbfe8b9e-e343-4ed5-bd81-01b27b4aa912

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.