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NDC 68062-9109-01 Pharmaskincare Acnecare Dermacontrol Cream 0.063 mg/2.5mL Details
Pharmaskincare Acnecare Dermacontrol Cream 0.063 mg/2.5mL
Pharmaskincare Acnecare Dermacontrol Cream is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Spa de Soleil. The primary component is BENZOYL PEROXIDE.
Product Information
NDC | 68062-9109 |
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Product ID | 68062-9109_5b4fdf3a-2bba-54b7-e053-2991aa0aca8c |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Pharmaskincare Acnecare Dermacontrol Cream |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | benzoyl peroxide |
Product Type | HUMAN OTC DRUG |
Dosage Form | LOTION |
Route | TOPICAL |
Active Ingredient Strength | 0.063 |
Active Ingredient Units | mg/2.5mL |
Substance Name | BENZOYL PEROXIDE |
Labeler Name | Spa de Soleil |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part333D |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 68062-9109-01 (68062910901)
NDC Package Code | 68062-9109-1 |
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Billing NDC | 68062910901 |
Package | 60 mL in 1 TUBE (68062-9109-1) |
Marketing Start Date | 2017-10-10 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5b4fdf3a-2bb9-54b7-e053-2991aa0aca8c Details
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
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
INGREDIENTS AND APPEARANCE
PHARMASKINCARE ACNECARE DERMACONTROL CREAM
benzoyl peroxide lotion |
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Labeler - Spa de Soleil (874682867) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Spa de Soleil | 874682867 | manufacture(68062-9109) |