FDA Label for Modesa Acne Treatment

View Indications, Usage & Precautions

Modesa Acne Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Zhejiang Jingwei Pharmaceutic Al Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients

Benzoyl peroxide  10%


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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