ACNECARE DERMACONTROL CREAM- salicylic acid liquid

Acnecare Dermacontrol Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Benzoyl Peroxide (5%)..........Acne Treatment

PURPOSE

Purpose

Acne Treatment

INDICATIONS & USAGE

For treatment of acne

WARNINGS

Warnings

For external use only

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

If swallowed, get medical help or contact a Poison Control Center right away. If excessive skin irritation develops or increases, discontinue use and consult a doctor. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

WHEN USING

When using this product

Skin irritation and dryness is more likely to occur if you use another topical acne medication while using this product. If irritation occurs, use only one topical acne medication at a time.

DOSAGE & ADMINISTRATION

Directions:

Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer 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 consult a doctor.

Sensitivity test for a new user: Apply product sparingly to one or two small affected areas during the first three days. If no discomfort occurs, follow the directions as stated.

INACTIVE INGREDIENT

Other Ingredients:

Aqua, Caprylic/Capric Triglyceride, Cetyl Alcohol, Ethoxydiglycol, Polyglyceryl-6 Distearate, Stearic Acid, Dimethicone, Jojoba Esters, Carbomer, Lactic Acid, Glycolic Acid, Hydroxyethylcellulose, Sodium Hydroxide, Polyglyceryl-3 Beeswax, 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), 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, Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Benzyl Alcohol, Dehydroacetic Acid. *Certified Organic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNECARE DERMACONTROL CREAM 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-8090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	3 mg  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
ETHOXYDIGLYCOL OLEATE (UNII: 843B4EZH9X)
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-8090-1	60 mL in 1 TUBE; Type 0: Not a Combination Product	12/23/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	12/23/2022

Labeler - Spa de Soleil (874682867)

Registrant - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-8090)