PHARMASKINCARE ACNECARE DERMACONTROL CREAM- benzoyl peroxide lotion 
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 Dermacontrol Cream

Active Ingredient

Benzoyl Peroxide 5.0%

Purpose

Acne Treatment

Warnings

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, Stearic Acid, Cetyl Alcohol, Ethoxydiglycol, Caprylic/Capric Triglyceride, Carbomer, Dimethicone, Jojoba Esters, Polyglyceryl-3 Beeswax, Polyglyceryl-6 Distearate, Lactic Acid, Glycolic Acid, Hydroxyethylcellulose, Sodium Hydroxide, Sodium PCA, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, BHT, Titanium Dioxide, *CO Glycerin, Glycerin, Citric Acid, Malic Acid, DMAE, Ubiquinone, Thioctic Acid, Gluconic Acid, Ascorbic Acid (Vitamin C), Malus Domestica Fruit Cell Culture Extract, Salicylic Acid, Tartaric Acid, *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, Xanthan Gum, Lecithin, Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Benzyl Alcohol, Dehydroacetic Acid

Warning

Keep out of reach of children.

Do Not Use

Do not use if you:

● have very sensitive skin

● are sensitive to benzoyl peroxide

Pharmaskincare AcnecareDermacontrol.jpg

Pharmaskincare AcnecareDermacontrol.jpg

PHARMASKINCARE ACNECARE DERMACONTROL CREAM 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-9109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE0.063 mg  in 2.5 mL
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68062-9109-160 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(68062-9109)

Revised: 10/2017
Document Id: 5b4fdf3a-2bba-54b7-e053-2991aa0aca8c
Set id: 5b4fdf3a-2bb9-54b7-e053-2991aa0aca8c
Version: 1
Effective Time: 20171011
 
Spa de Soleil