Acnecare Dermacontrol Cream

Acnecare Dermacontrol Cream
SPL v2
SPL
SPL Set ID f08401ce-bb52-3e6b-e053-2995a90ad595
Route
TOPICAL
Published
Effective Date 2022-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (3 mg)
Inactive Ingredients
Cetyl Alcohol Water Ethoxydiglycol Oleate Caprylic/capric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-23

Description

Active ingredient Purpose Benzoyl Peroxide (5%)..........Acne Treatment


Medication Information

Warnings and Precautions

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.

Indications and Usage

For treatment of acne

Dosage and 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.

Description

Active ingredient Purpose Benzoyl Peroxide (5%)..........Acne Treatment

Section 50565-1

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

Section 50567-7

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.

Section 51727-6

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

Section 51945-4

Section 55105-1

Purpose

Acne Treatment

Section 55106-9

Active ingredient Purpose

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


Structured Label Content

Indications and Usage (34067-9)

For treatment of acne

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Acne Treatment

Section 55106-9 (55106-9)

Active ingredient Purpose

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


Advanced Ingredient Data


Raw Label Data

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