FDA Label for Derma Pella Acne Care
View Indications, Usage & Precautions
Derma Pella Acne Care Product Label
The following document was submitted to the FDA by the labeler of this product Pella Pharmaceuticals 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.
Form And Presentation
Gel: Plastic Tube, 25 g
Active Ingredient
Salicylic Acid
Inactive Ingredients
Aqua, Glycerin, Ethoxydiglycol, Polyacrylamide, Ammonium Acryloyldimethyltaurate/VP Copolymer, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Niacinamide (Vitamin B3), C 13-14 Isoparaffin, Phenoxyethanol, Sodium Hydroxide, Allantoin, Laureth-7, Disodium EDTA, Ethylhexylglycerin.
Purpose
Acne care gel
Properties
A lightweight, water-based alcohol-free gel.
This product contains a beta hydroxyl acid (BHA) which is a salicylic acid that clears out clogged pores, reduces blemishes, and helps to minimize blackheads and breakouts. It dissolves excess sebum, making it suitable for acne-prone skin.
And also, it contains Tea tree oil which has soothing properties and improves the appearance of marks.
In addition to Niacinamide (Vitamin B3) which works best to soothe and lighten skin, visibly minimize pores, and improve uneven skin tone, reduce dark spots and acne spots.
It contains Allantoin which is an effective moisturizing ingredient used for it is gentle and non-irritating qualities.
Paraben free, Alcohol free, Fragrance free.
Indications
Helps to clear acne and reduce formation of new blackheads and whiteheads.
Precautions
Keep out of reach of children
Warnings
- For external use only.
- Discontinue if excessive skin irritation develops or increases. If irritation persists, consult with a physician or pharmacist.
- Avoid direct contact with eyes, if contact occurs, rinse thoroughly with water.
Contraindications
Hypersensitivity to any of the components.
Side Effects
Skin irritations, dryness, redness more likely to occur when using another topical acne product at the same time, if irritation occurs, use only one product at a time.
Dosage And Administration
- Cleanse skin thoroughly before applying product.
- Dry your face and then apply a thin layer one to three times daily.
- Because excessive drying of the skin may occur, start with one application daily, and then gradually increase to two or three times daily, if needed.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Storage Conditions
Store below 30 ◦C.
* Please review the disclaimer below.