MODESA ACNE TREATMENT- benzoyl peroxide cream

Modesa by

Drug Labeling and Warnings

Modesa by is a Otc medication manufactured, distributed, or labeled by Zhejiang Jingwei Pharmaceutic Al Co., Ltd., Zhejiang Jingwei Pharmaceutical Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Benzoyl peroxide  10%

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

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MODESA  ACNE TREATMENT
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55621-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55621-015-01	1 in 1 CARTON	08/03/2017	06/01/2020
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/03/2017	06/01/2020

Labeler - Zhejiang Jingwei Pharmaceutic Al Co., Ltd. (530876549)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Jingwei Pharmaceutical Co Ltd		530876549	manufacture(55621-015)