Dermaharmony 5% Benzoyl Peroxide Bar

Dermaharmony 5% Benzoyl Peroxide Bar
SPL v2
SPL
SPL Set ID c7ceae0d-3215-1f83-e053-2995a90a60bc
Route
TOPICAL
Published
Effective Date 2021-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (5 g)
Inactive Ingredients
Ferric Oxide Yellow Ferric Oxide Red 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 2021-07-29

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, iron oxides (red and yellow), lactic acid

Section 51945-4

dermaharmony

5% 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 5%


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, iron oxides (red and yellow), lactic acid

Section 51945-4 (51945-4)

dermaharmony

5% 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 5%


Advanced Ingredient Data


Raw Label Data

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