Acne Care Gel

Manufacturer
Pella Pharmaceuticals Co. Ltd
Effective date
2024-02-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:14

Label at a glance#

ProductDerma Pella Acne Care
Active ingredientSALICYLIC ACID
Label structure14 sections

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 and handling

Store below 30 ◦ C.

Label contents#

Full prescribing information#

Form and Presentation

HOW SUPPLIED SECTION

Gel: Plastic Tube, 25 g

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Acne care gel

Properties

DESCRIPTION SECTION

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

INDICATIONS & USAGE SECTION

Helps to clear acne and reduce formation of new blackheads and whiteheads.

Precautions

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Warnings

WARNINGS SECTION

- 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

CONTRAINDICATIONS SECTION

Hypersensitivity to any of the components.

Side Effects

ADVERSE REACTIONS SECTION

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

DOSAGE & ADMINISTRATION SECTION

- 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

STORAGE AND HANDLING SECTION

Store below 30 ◦C.

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary PackagePrimary Package

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secondary PackageSecondary Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2568117salicylic acid 1.8 % Topical GelPSN2
2568117salicylic acid 0.018 MG/MG Topical GelSCD2
2568117salicylic acid 1.8 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-795-01Derma Pella Acne Care1 in 1 CARTONGEL12
82160-795-01Derma Pella Acne Care25 g in 1 TUBEGEL252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-795DERMA PELLA ACNE CARE (SALICYLIC ACID) GEL [PELLA PHARMACEUTICALS CO. LTD]22 package rows20240202_fea499ac-c9b9-4474-e053-6394a90aea03.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82160-79582160-795-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
105427b3-4b0c-c73a-e063-6394a90aa693fea499ac-c9b9-4474-e053-6394a90aea032024-02-01Warnings, Adverse reactionsExact identifier
spl id: 105427b3-4b0c-c73a-e063-6394a90aa693
spl set id: fea499ac-c9b9-4474-e053-6394a90aea03

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.