Acne Cleanser

Acne Cleanser
SPL v2
SPL
SPL Set ID 0a90a5e9-65e7-f885-e063-6394a90a8bf8
Route
TOPICAL
Published
Effective Date 2023-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1.15 mg)
Inactive Ingredients
Sodium Methyl 2-sulfolaurate Disodium 2-sulfolaurate Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-19

Description

Active ingredient Purpose Salicylic Acid (0.5%)..........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:

Wash affected area twice daily.

Description

Active ingredient Purpose Salicylic Acid (0.5%)..........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, Sodium Methyl 2-Sulfolaurate, Disodium 2-Sulfolaurate, Glycerin, Ethoxydiglycol, Hydroxyethylcellulose, Guar Hydroxypropyltrimonium Chloride, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate (Hyaluronic Acid), Sodium Hydroxide, *CO Glycerin, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Benzyl Alcohol, Dehydroacetic Acid, Fragrance. *CO Certified Organic

Section 51945-4

Section 55105-1

Purpose

Acne Treatment

Section 55106-9

Active ingredient Purpose

Salicylic Acid (0.5%)..........Acne Treatment


Structured Label Content

Indications and Usage (34067-9)

For treatment of acne

Dosage and Administration (34068-7)

Directions:

Wash affected area twice daily.

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, Sodium Methyl 2-Sulfolaurate, Disodium 2-Sulfolaurate, Glycerin, Ethoxydiglycol, Hydroxyethylcellulose, Guar Hydroxypropyltrimonium Chloride, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate (Hyaluronic Acid), Sodium Hydroxide, *CO Glycerin, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Benzyl Alcohol, Dehydroacetic Acid, Fragrance. *CO Certified Organic

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Acne Treatment

Section 55106-9 (55106-9)

Active ingredient Purpose

Salicylic Acid (0.5%)..........Acne Treatment


Advanced Ingredient Data


Raw Label Data

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