Sei Bella Clarity Clear Precision Acne Spot Treatment

Sei Bella Clarity Clear Precision Acne Spot Treatment
SPL v2
SPL
SPL Set ID 193667e8-3a4d-9270-e063-6294a90a1c26
Route
TOPICAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (1.5 g)
Inactive Ingredients
Steareth-2 Potassium Sorbate Glycerin Glyceryl Monostearate Allantoin Peg-100 Stearate Cetostearyl Alcohol Chlorella Vulgaris Cetyl Alcohol Steareth-21 Panthenol Stearic Acid Polysorbate 60 Niacinamide Phenoxyethanol Ethyl Macadamiate Water Polyglycerin-3 Levomenol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Benzoyl peroxide 10%

Purpose

Acne Treatment


Medication Information

Indications and Usage

Uses for the treatment and management of acne

Purpose

Acne Treatment

Dosage and Administration

Directions

  • cleanse and tone skin thoroughly before application
  • cover the entire affected area with a thin layer 1-3 times daily
  • because excessive drying of the skin may occur, start with one application daily, and then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce daily 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 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 above.

Other Information Store at room temperature 68-77°. Protect from freezing.

Description

Benzoyl peroxide 10%

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Section 50566-9

Stop use and ask a doctor if excessive irritation of the skin develops

Section 50567-7

When using this product

  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If this occurs, only one medication should be used unless otherwise directed by a doctor.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with 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 lower concentration.
Section 50570-1

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Section 51727-6

Aqua (Water/Eau), Benzoyl Peroxide Gel, Glycerin, Panthenol, Ethyl Macadamiate, Cetyl Alcohol, Stearic Acid, Niacinamide, Polyglyceryl-3 Methyl Glucose Distearate, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Steareth-21, Phenoxyethanol, Bisabolol, Polysorbate 60, Steareth-2, Xanthan Gum, Allantoin, Potassium Sorbate, Chlorella Vulgaris Extract.

Section 51945-4

Warnings

For external use only.

Active Ingredient

Benzoyl peroxide 10%


Structured Label Content

Indications and Usage (34067-9)

Uses for the treatment and management of acne

Dosage and Administration (34068-7)

Directions

  • cleanse and tone skin thoroughly before application
  • cover the entire affected area with a thin layer 1-3 times daily
  • because excessive drying of the skin may occur, start with one application daily, and then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce daily 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 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 above.

Other Information Store at room temperature 68-77°. Protect from freezing.

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Section 50566-9 (50566-9)

Stop use and ask a doctor if excessive irritation of the skin develops

Section 50567-7 (50567-7)

When using this product

  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If this occurs, only one medication should be used unless otherwise directed by a doctor.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with 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 lower concentration.
Section 50570-1 (50570-1)

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Section 51727-6 (51727-6)

Aqua (Water/Eau), Benzoyl Peroxide Gel, Glycerin, Panthenol, Ethyl Macadamiate, Cetyl Alcohol, Stearic Acid, Niacinamide, Polyglyceryl-3 Methyl Glucose Distearate, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Steareth-21, Phenoxyethanol, Bisabolol, Polysorbate 60, Steareth-2, Xanthan Gum, Allantoin, Potassium Sorbate, Chlorella Vulgaris Extract.

Section 51945-4 (51945-4)

Purpose

Acne Treatment

Warnings

For external use only.

Active Ingredient

Benzoyl peroxide 10%


Advanced Ingredient Data


Raw Label Data

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