Dermaharmony 10% Benzoyl Peroxide Bar

Dermaharmony 10% Benzoyl Peroxide Bar
SPL v2
SPL
SPL Set ID c7083b69-fed4-d497-e053-2a95a90a1a8c
Route
TOPICAL
Published
Effective Date 2021-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (10 g)
Inactive Ingredients
Polyoxyl 20 Cetostearyl Ether Lactic Acid Coco Glucoside Sodium Cocoyl Isethionate Stearic Acid Coconut Acid Cetostearyl Alcohol Sodium Isethionate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-13

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Use

for the management of acne

Dosage and Administration

Directions

  • using warm water, wash affected area for 1-2 minutes
  • rinse thoroughly and pat dry with a clean towel
  • start with 1 application daily, then gradually increase to 2-3 times daily if needed or as directed by a doctor
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

Store in a dry place between 59-86°F (15-30°C)

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifirritation becomes severe.

Section 50567-7

When using this product

  • 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 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.
  • 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.
Section 50570-1

Do not useif you

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

Inactive ingredients

Sodium cocoyl isethionate, stearic acid, coconut fatty acid, sodium isethionate, water. coco glucoside, cetearyl alcohol & ceteareth-20, lactic acid

Section 51945-4

dermaharmony

10% Benzoyl Peroxide

Cleansing Bar

FOR THE TREATMENT OF ACNE

Reduces: pimples-blemishes-whiteheads-blackheads

NET WT 4 OZ (113G)

Section 53413-1

Questions?

1-800-827-3730

www.dermaharmony.com

Section 55105-1

Purpose

Acne medication

Section 55106-9

Active ingredient

Benzoyl peroxide 10%


Structured Label Content

Indications and Usage (34067-9)

Use

for the management of acne

Dosage and Administration (34068-7)

Directions

  • using warm water, wash affected area for 1-2 minutes
  • rinse thoroughly and pat dry with a clean towel
  • start with 1 application daily, then gradually increase to 2-3 times daily if needed or as directed by a doctor
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

Store in a dry place between 59-86°F (15-30°C)

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifirritation becomes severe.

Section 50567-7 (50567-7)

When using this product

  • 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 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.
  • 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.
Section 50570-1 (50570-1)

Do not useif you

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

Inactive ingredients

Sodium cocoyl isethionate, stearic acid, coconut fatty acid, sodium isethionate, water. coco glucoside, cetearyl alcohol & ceteareth-20, lactic acid

Section 51945-4 (51945-4)

dermaharmony

10% Benzoyl Peroxide

Cleansing Bar

FOR THE TREATMENT OF ACNE

Reduces: pimples-blemishes-whiteheads-blackheads

NET WT 4 OZ (113G)

Section 53413-1 (53413-1)

Questions?

1-800-827-3730

www.dermaharmony.com

Section 55105-1 (55105-1)

Purpose

Acne medication

Section 55106-9 (55106-9)

Active ingredient

Benzoyl peroxide 10%


Advanced Ingredient Data


Raw Label Data

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