Acne Free Oil Free Acne Cleanser 2.5 % Benzoyl Peroxide

Acne Free Oil Free Acne Cleanser 2.5 % Benzoyl Peroxide
SPL v6
SPL
SPL Set ID c939847a-72cc-96fa-e053-2a95a90a4f9c
Route
TOPICAL
Published
Effective Date 2021-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-01

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 you

• have very sensitive skin

• are sensitive to benzoyl peroxide

Pakage Labeling:

Active Ingredient

Benzoyl peroxide 2.5%

Questions Or Comments?

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

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 you

• have very sensitive skin

• are sensitive to benzoyl peroxide

Pakage Labeling:

Active Ingredient (Active ingredient)

Benzoyl peroxide 2.5%

Questions Or Comments? (Questions or comments?)

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

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 If (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.


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