DERMA PELLA ACNE WASH FOR OILY SKIN- salicylic acid solution 
Pella Pharmaceuticals Co. Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Forms and Presentation

Solution: Plastic Bottle, 150 ml

Active Ingredient

Salicylic Acid

Inactive Ingredients

Aqua, Glycerin, Cocamidopropyl Betain, Sodium C14-16 Olefin Sulfonate, Butylene Glycol, Polysorbate 20, Sodium Benzoate, Allantoin, Potassium Sorbate, Disodium EDTA, Parfum, Citric Acid, 2-Bromo-2-Nitropropane-1,3-Diol, Tetrasodium EDTA, Bacillus Ferment

Purpose

Facial Cleanser for Oily Skin

Properties

A lightweight, translucent, water-based Alcohol and Sulfate free facial foaming cleanser.

This product contains a beta hydroxyl acid (BHA) which is a salicylic acid that helps remove dead skin cells, reduce blackheads and the appearance of pores, so it prevents acne.

And also it contains Bacillus Ferment which is a multifunctional biotechnological ingredient obtains from microorganism isolated from natural clay, offers a cleaner smother and more beautiful skin by:

- P. acne biofilm inhibition.
- Reduced inflammatory response to P. acne.
- Skin regenerating effect.
- Cleansing activity.
- Antioxidant response determined by reactive oxygen species (ROS).

Also it contains Allantoin which is an effective moisturizing ingredient used for it is gentle and non-irritating qualities.

Paraben free, Alcohol free, SLS free, SLES free.

Indications

Non-irritating foaming cleanser formulated for acne-prone skins, helps gently exfoliate skin without over drying, deep cleans pores control excess oil, unclog pores and prevent new acne from forming.

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

It is well tolerated product but mild irritation, dryness, redness may occur.

Dosage and Administration

- Use it twice a day, morning and night.
- Pump 2 - 3 times onto the tips of your fingers.
- Massage gently over wet skin in a circular motion for 1 min, avoiding eye area.
- Rinse thoroughly, pat skin dry.
- Follow with non comedogenic moisturizer.
- If excessive dryness or peeling occurs, reduce usage.

Storage Conditions

Store below 30 C.

Primary Package

DERMA PELLA ACNE WASH FOR OILY SKIN 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82160-764
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BRONOPOL (UNII: 6PU1E16C9W)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALLANTOIN (UNII: 344S277G0Z)  
EDETATE SODIUM (UNII: MP1J8420LU)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82160-764-01150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00605/16/2023
Labeler - Pella Pharmaceuticals Co. Ltd (562370925)

Revised: 6/2023
Document Id: fe667ac6-4606-0670-e053-6294a90aa1b8
Set id: fe667ac6-4605-0670-e053-6294a90aa1b8
Version: 1
Effective Time: 20230618
 
Pella Pharmaceuticals Co. Ltd