Acne Free Severe Acne 24 Hr Acne Clearing System Kit

Acne Free Severe Acne 24 Hr Acne Clearing System Kit
SPL v6
SPL
SPL Set ID c939681e-ea93-31ce-e053-2a95a90a8c70
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
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 Ceramide Ap Phytosphingosine Cholesterol Carbomer Homopolymer, Unspecified Type Ceramide 1 Butylene Glycol Alkyl (c12-15) Benzoate Glyceryl Monostearate Peg-100 Stearate Cetostearyl Alcohol Phenoxyethanol Polysorbate 60 Dimethicone Cetyl Alcohol Levomenol Edetate Sodium Ethylhexylglycerin Methylisothiazolinone Benzalkonium Chloride Pseudopterogorgia Elisabethae Ginger Chamomile Alcohol Leuconostoc/radish Root Ferment Filtrate Methylparaben Edetate Disodium Anhydrous Ethylparaben Methyl Methacrylate/glycol Dimethacrylate Crosspolymer

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

80861 004 01

80861 011 01

Kit 80861 010 01

Active Ingredient

Benzoyl peroxide 2.5%

Inactive Ingredients

water, butylene glycol, C12-15 alkyl benzoate, glycerin, glyceryl stearate, PEG-100 stearate, cetearyl alcohol, phenoxyethanol, hydroxypropyl starch phosphate, polysorbate 60, dimethicone, xanthan gum, cetyl alcohol, bisabolol, tetrasodium EDTA, ethylhexylglycerin,  methylisothiazolinone, benzalkonium chloride, sea whip extract, zingiber officinale (ginger) root extract, chamomilla recutita (matricaria) flower extract, alcohol, leuconostoc/radish root ferment filtrate, methylparaben, disodium EDTA, ethylparaben, methyl methacrylate/glycol  dimethacrylate crosspolymer

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

80861 004 01 (80861-004-01)

80861 011 01 (80861-011-01)

Kit 80861 010 01 (KIT 80861-010-01)

Active Ingredient (Active ingredient)

Benzoyl peroxide 2.5%

Inactive Ingredients (Inactive ingredients)

water, butylene glycol, C12-15 alkyl benzoate, glycerin, glyceryl stearate, PEG-100 stearate, cetearyl alcohol, phenoxyethanol, hydroxypropyl starch phosphate, polysorbate 60, dimethicone, xanthan gum, cetyl alcohol, bisabolol, tetrasodium EDTA, ethylhexylglycerin,  methylisothiazolinone, benzalkonium chloride, sea whip extract, zingiber officinale (ginger) root extract, chamomilla recutita (matricaria) flower extract, alcohol, leuconostoc/radish root ferment filtrate, methylparaben, disodium EDTA, ethylparaben, methyl methacrylate/glycol  dimethacrylate crosspolymer

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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