PHARMASKINCARE ACNECARE EXFOLIATOR- salicylic acid solution

Pharmaskincare Acnecare Exfoliator by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

Warnings

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.

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.

Massage Acnecare Exfoliator onto cleansed, damp skin with fingertips using a circular motion. Rinse well with lukewarm water and pat dry. Avoid use on flare-ups and breakouts.

Uses:

For the treatment of acne.

Inactive Ingredients:

Water, Phytelephas Aequatorialis Seed Powder, Glycerin, Glyceryl Stearate SE, Cocamidopropyl Betaine, Carthamus Tinctorius (Safflower) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Hydroxyethylcellulose, *CO Glycerin, *CO Aloe Barbadensis Leaf Juice, Ananas Sativus (Pineapple) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Papain, *CO Aesculus Hippocastanum (Horse Chestnut) Seed Extract, *CO Prunus Armeniaca (Apricot) Fruit Extract, *CO Rosa Centifolia Flower Extract, *CO Rosmarinus Officinalis (Rosemary) Leaf Extract, **Squalane, DMAE, Thioctic Acid, Ubiquinone, Carica Papaya (Papaya) Fruit Extract, Sea Salt (Dead Sea Salt), Malus Domestica Fruit Cell Culture Extract, Xanthan Gum, Citric Acid, Lactic Acid, Malic Acid, Gluconic Acid, Ascorbic Acid (Vitamin C), Lecithin, Glycolic Acid, Tartaric Acid, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Benzyl Alcohol, Fragrance, Dehydroacetic Acid

Warning

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

Pharmaskincare AcnecareExfoliator.jpg

INGREDIENTS AND APPEARANCE

PHARMASKINCARE ACNECARE EXFOLIATOR 
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-9110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.013 mg  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SAFFLOWER OIL (UNII: 65UEH262IS)
PHYTELEPHAS AEQUATORIALIS SEED (UNII: 2DJN5A6ONH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-9110-1	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(68062-9110)