Dermesse Benzoyl Peroxide 5% Gel

Dermesse Benzoyl Peroxide 5% Gel
SPL v4
SPL
SPL Set ID a0e4581a-ea6b-4c82-998f-4ea4103c857b
Route
TOPICAL
Published
Effective Date 2021-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Allantoin Aloe Vera Leaf Benzyl Alcohol Carbomer Interpolymer Type A (55000 Cps) Edetate Disodium Disodium Laureth Sulfosuccinate Glycerin Panthenol Polyethylene Glycol 400 Ppg-14 Palmeth-60 Hexyl Dicarbamate Hyaluronate Sodium Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-07-18

Description

Benzoyl Peroxide 5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl Peroxide 5%

Uses:

For the treatment of acne.

Section 51945-4

Warnings:

For external use only.

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 to 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 ask a doctor.

Questions?:

866-494-4466, Mon-Fri 8:00AM-5:00PM

Dist. By Axia Medical Solutions, 2105 Camino Vida Roble, Carlsbad, Ca. 92011

www.dermesse.com     866-494-4466 office, 760-931-8267 fax

Active Ingredient:

Benzoyl Peroxide 5%

Do Not Use If You:

• Have sensitive skin. • Are sensitive to benzoyl peroxide.

Other Information:

• Store at controlled room temperature 15-30°C (59-86°F)

Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Disodium Laureth Sulfosuccinate, Glycerin, Panthenol, PEG-8, PEG-14 Palmeth-60 Hexyl Dicarbamate, Sodium Hyaluronate, Triethanolamine, and Water.

When Using the Product:

• Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If this occurs only use one topical acne medication at a time • Avoid unnecessary sun exposure and use a sunscreen • Avoid contact with the 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 a lower concentration.

Stop Use and Ask A Doctor If:

Irritation become severe.

Keep Out of Reach of Children.

If swallowed get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses: (USES:)

For the treatment of acne.

Section 51945-4 (51945-4)

Purpose

Acne Treatment

Warnings: (WARNINGS:)

For external use only.

Directions: (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 to 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 ask a doctor.

Questions?:

866-494-4466, Mon-Fri 8:00AM-5:00PM

Dist. By Axia Medical Solutions, 2105 Camino Vida Roble, Carlsbad, Ca. 92011

www.dermesse.com     866-494-4466 office, 760-931-8267 fax

Active Ingredient:

Benzoyl Peroxide 5%

Do Not Use If You: (Do not use if you:)

• Have sensitive skin. • Are sensitive to benzoyl peroxide.

Other Information: (OTHER INFORMATION:)

• Store at controlled room temperature 15-30°C (59-86°F)

Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Disodium Laureth Sulfosuccinate, Glycerin, Panthenol, PEG-8, PEG-14 Palmeth-60 Hexyl Dicarbamate, Sodium Hyaluronate, Triethanolamine, and Water.

When Using the Product: (When using the product:)

• Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If this occurs only use one topical acne medication at a time • Avoid unnecessary sun exposure and use a sunscreen • Avoid contact with the 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 a lower concentration.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

Irritation become severe.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)