DERMA PELLA ACNE CARE- salicylic acid gel

Derma Pella Acne Care by

Drug Labeling and Warnings

Derma Pella Acne Care by is a Otc medication manufactured, distributed, or labeled by Pella Pharmaceuticals Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Primary Package

Secondary Package

INGREDIENTS AND APPEARANCE

DERMA PELLA ACNE CARE 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82160-795
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	18 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
LAURETH-7 (UNII: Z95S6G8201)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TEA TREE OIL (UNII: VIF565UC2G)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ALLANTOIN (UNII: 344S277G0Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82160-795-01	1 in 1 CARTON	03/30/2023
1		25 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	03/30/2023

Labeler - Pella Pharmaceuticals Co. Ltd (562370925)