Pharmaskincare Acnecare Dermacontrol Cream

Manufacturer
Spa de Soleil
Effective date
2017-10-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:40

Label at a glance#

ProductPharmaskincare Acnecare Dermacontrol Cream
Active ingredientBENZOYL PEROXIDE
Label structure9 sections

Indications and uses

For the treatment of acne.

Dosage and administration

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 da...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Warnings

WARNINGS SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

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:

INDICATIONS & USAGE SECTION

For the treatment of acne.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Do Not Use

OTC - DO NOT USE SECTION

Do not use if you:

● have very sensitive skin

● are sensitive to benzoyl peroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pharmaskincare AcnecareDermacontrol.jpg

Pharmaskincare AcnecareDermacontrol.jpgPharmaskincare AcnecareDermacontrol.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68062-9109-12025-01-30C16284748780-12cef2736-aaa3-d83d-e063-dadaa90ab31fPharmaskincare Acnecare Dermacontrol Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68062-9109-1Pharmaskincare Acnecare Dermacontrol Cream60 mL in 1 TUBELOTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68062-9109PHARMASKINCARE ACNECARE DERMACONTROL CREAM (BENZOYL PEROXIDE) LOTION [SPA DE SOLEIL]1Legacy NDC, 1 package rows20171012_5b4fdf3a-2bb9-54b7-e053-2991aa0aca8c.zip

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68062-910968062-9109-1

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5b4fdf3a-2bba-54b7-e053-2991aa0aca8c5b4fdf3a-2bb9-54b7-e053-2991aa0aca8c2017-10-11WarningsExact identifier
spl id: 5b4fdf3a-2bba-54b7-e053-2991aa0aca8c
spl set id: 5b4fdf3a-2bb9-54b7-e053-2991aa0aca8c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.