PHARMASKINCARE ACNECARE EXFOLIATOR- salicylic acid solution 
Spa de Soleil

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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Pharmaskincare Acnecare Exfoliator

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

Warnings

Warnings

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.

Pharmaskincare AcnecareExfoliator.jpg

Pharmaskincare AcnecareExfoliator.jpg

PHARMASKINCARE ACNECARE EXFOLIATOR 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-9110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.013 mg  in 2.5 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
PHYTELEPHAS AEQUATORIALIS SEED (UNII: 2DJN5A6ONH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68062-9110-1120 mL in 1 TUBE; Type 0: Not a Combination Product10/10/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/10/2017
Labeler - Spa de Soleil (874682867)
Establishment
NameAddressID/FEIBusiness Operations
Spa de Soleil874682867manufacture(68062-9110)

Revised: 10/2017
Document Id: 5b501566-02a5-1801-e053-2a91aa0ae5da
Set id: 5b501566-02a4-1801-e053-2a91aa0ae5da
Version: 1
Effective Time: 20171011
 
Spa de Soleil