Oil Free Deep Cleansing Duo, Cleansing Brush + Oil-free Acne Cleanser

Oil Free Deep Cleansing Duo, Cleansing Brush + Oil-free Acne Cleanser
SPL v6
SPL
SPL Set ID c7a675fa-b6c0-6237-e053-2a95a90a0406
Route
TOPICAL
Published
Effective Date 2021-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (25 mg)
Inactive Ingredients
Water Glycerin Propylene Glycol Cocamidopropyl Hydroxysultaine Sodium C14-16 Olefin Sulfonate Xanthan Gum Citric Acid Monohydrate Potassium Hydroxide Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Sodium Lauroyl Lactylate Glycolic Acid Ceramide Np Ceramide Ap Phytosphingosine Cholesterol Carbomer Homopolymer, Unspecified Type Ceramide 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-08-16

Description

Benzoyl peroxide 2.5%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Benzoyl peroxide 2.5%

Use

for the treatment of acne

Warnings

For external use only

Directions

• use every morning and evening

• apply a dime-size amount to damp skin and gently massage, avoiding the eye area

• rinse well

• use wash on entire affected area one to two times daily

• because excessive drying of the skin may occur, start with washing once daily, then gradually increase to two times daily if needed or as directed by a doctor

• if bothersome dryness or peeling occurs, reduce cleansing 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.

• may be used on chest or back

Do Not Use

if yo u

• have very sensitive skin

• are sensitive to benzoyl peroxide

Active Ingredient

Benzoyl peroxide 2.5%

Package Labeling:

Inactive Ingredients

water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, citric acid, potassium hydroxide, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium lauroyl lactylate, glycolic acid, ceramide NP, ceramide AP,

phytosphingosine, cholesterol, carbomer, ceramide EOP

Questions Or Comments?

1-888-768-2913

When Using 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.

• 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 skin irritation becomes severe

Keep Out of Reach of Children.

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


Structured Label Content

Use

for the treatment of acne

Purpose

Acne treatment

Warnings

For external use only

Directions

• use every morning and evening

• apply a dime-size amount to damp skin and gently massage, avoiding the eye area

• rinse well

• use wash on entire affected area one to two times daily

• because excessive drying of the skin may occur, start with washing once daily, then gradually increase to two times daily if needed or as directed by a doctor

• if bothersome dryness or peeling occurs, reduce cleansing 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.

• may be used on chest or back

Do Not Use (Do not use)

if yo u

• have very sensitive skin

• are sensitive to benzoyl peroxide

Active Ingredient (Active ingredient)

Benzoyl peroxide 2.5%

Package Labeling:

Inactive Ingredients (Inactive ingredients)

water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, citric acid, potassium hydroxide, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium lauroyl lactylate, glycolic acid, ceramide NP, ceramide AP,

phytosphingosine, cholesterol, carbomer, ceramide EOP

Questions Or Comments? (Questions or comments?)

1-888-768-2913

When Using This Product (When using 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.

• 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  (Stop use and ask a doctor )

if skin irritation becomes 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

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