Form And Presentation
Gel: Plastic Tube, 25 g
Derma Pella Acne Care
FDA Label NDC 82160-795
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pella Pharmaceuticals Co. Ltd for the product Derma Pella Acne Care (NDC 82160-795). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding form and presentation, active ingredient, inactive ingredients, purpose, properties, indications, precautions, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
