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
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
-
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
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MODESA ACNE TREATMENT
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55621-017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 10 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:55621-017-01 1 in 1 CARTON 08/20/2017 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 Drug M006 08/20/2017 Labeler - Zhejiang Jingwei Pharmaceutic Al Co., Ltd. (530876549) Establishment Name Address ID/FEI Business Operations Zhejiang Jingwei Pharmaceutic Al Co., Ltd. 530876549 manufacture(55621-017)