PHARMASKINCARE ACNECARE CLEANSER- benzoyl peroxide solution

Pharmaskincare Acnecare Cleanser by

Drug Labeling and Warnings

Pharmaskincare Acnecare Cleanser by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

Warnings

• For external use only.
• When using this product : skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with the eyes, lips, and mouth
• avoid contact with hair and dyed fabrics, which may be bleached by this product
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration. Stop use and ask a doctor if irritation becomes severe

Do not use if you:

● have very sensitive skin

● are sensitive to benzoyl peroxide

Directions

Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.

● If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

● If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated

Uses:

For the treatment of acne.

Inactive Ingredients:

Water, Sodium Cocoyl Isethionate, Stearic Acid, Dimethyl Isosorbide, Sodium C14-16 Olefin Sulfonate, Glycerin, Polyquaternium-7, Hydroxyethylcellulose, PEG-7 Glyceryl Cocoate, Glyceryl Stearate, Glyceryl Stearate SE, Guar Hydroxypropyltrimonium Chloride, Panthenol, Aloe Barbadensis Juice Extract, *CO Glycerin, Ascorbic Acid (Vitamin C), Thioctic Acid, Ubiquinone, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Phenoxyethanol, Ethylhexylglycerin, Fragrance

Warning

Keep out of reach of children.

Do Not Use

Do not use if you:

● have very sensitive skin

● are sensitive to benzoyl peroxide

PRINCIPAL DISPLAY PANEL

Pharmaskincare Acnecare Cleanser.jpg

INGREDIENTS AND APPEARANCE

PHARMASKINCARE ACNECARE CLEANSER 
benzoyl peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-9107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	0.063 mg  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-9107-1	120 mL in 1 TUBE; Type 0: Not a Combination Product	10/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/10/2017

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-9107)