FDA Label for Acne Spot Treatment
View Indications, Usage & Precautions
Acne Spot Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Monat Global Corp. 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 Ingredient
Benzoyl Peroxide 5.00%
Otc - Purpose
Purpose
Acne Treatment
Indications & Usage
Uses
- For the treatment of acne
Warnings
For external use only
Do Not Use If
Do not use if you
- have very sensitive skin
- are sensitive to benzoyl peroxide
Otc - When Using
When using this product
- skin irritation and dryness are more likely to occur if you use another topicalk acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time.
- avoid unnecessary sun exposure and use sunscreen
- avoid contact with eyes, lips, and mouth.
- avoid contact with hair and dyed fabrics, which may be bleached by this product.
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Stop Use And Consult
Stop use and consult with a doctor if
- irritation becomes severe.
Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.
Directions
Directions
- Clean skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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 sak a doctor.
Sensitivity Test for a new User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
Inactive Ingredient
Inactive Ingredients
Water, Isostearyl Alcohol, Glycerin, Pentylene Glycol, Silica, Hamamelis Virginiana (Witch Hazel) Water, Epilobium Angustifolium Flower/Leaf/Stem Extract, Phragmites Communis Extract, Poria Cocos Extract, Niacinamide, Tocopheryl Acetate, Carbomer, Potassium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA.
Questions Or Comments
Questions or comments?
Toll-free number 1-800-878-1978
Primary Package
Outer Package
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