Proactiv ®

Proactiv ®
SPL v9
SPL
SPL Set ID 85c22f3a-b6c5-44a2-959c-532c6456ec30
Route
TOPICAL
Published
Effective Date 2022-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (2.5 g)
Inactive Ingredients
Water Magnesium Aluminum Silicate Glyceryl Monostearate Peg-100 Stearate Sorbitol Dimethyl Isosorbide Tridecyl Stearate Neopentyl Glycol Dicaprylate/dicaprate Paraffin Cetyl Esters Wax Chamaemelum Nobile Tridecyl Trimellitate Trisodium Sulfosuccinate Peg-12 Dimethicone (300 Cst) Hyaluronate Sodium Propylene Glycol Sodium Pyrrolidone Carboxylate Xanthan Gum Phenoxyethanol Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-10-21

Description

Drug Facts

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Drug Facts

Use

for the management of acne

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not useif you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Warnings

For external use only

Directions
  • Sensitivity Test for a New User .  Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
  • cover the entire affected area with a thin layer and rinse thoroughlyone to three times daily.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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.
Active Ingredient

Benzoyl peroxide 2.5%

Inactive Ingredients

water, magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, sorbitol, dimethyl isosorbide, disodium PEG-12 dimethicone sulfosuccinate, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, paraffin, cetyl esters, tridecyl trimellitate, trisodium sulfosuccinate, PEG-12 dimethicone, xanthan gum, imidazolidinyl urea, fragrance, methylparaben, sodium sulfate, propylparaben, sodium PCA, propylene glycol, anthemis nobilis flower extract, phenoxyethanol, sodium hyaluronate

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.
Questions Or Comments?  

1-800-950-4695

Stop Use and Ask A Doctor If
  • irritation becomes severe.
Principal Display Panel 120 Ml Carton

proactiv®

CLEANSE

1

RENEWING

CLEANSER

4 FL. OZ. (120 mL)



benzoyl peroxide acne medication


Structured Label Content

Use

for the management of acne

Section 42229-5 (42229-5)

Drug Facts

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 50570-1 (50570-1)

Do not useif you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Purpose

Acne treatment

Warnings

For external use only

Directions
  • Sensitivity Test for a New User .  Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
  • cover the entire affected area with a thin layer and rinse thoroughlyone to three times daily.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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.
Active Ingredient (Active ingredient)

Benzoyl peroxide 2.5%

Inactive Ingredients (Inactive ingredients)

water, magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, sorbitol, dimethyl isosorbide, disodium PEG-12 dimethicone sulfosuccinate, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, paraffin, cetyl esters, tridecyl trimellitate, trisodium sulfosuccinate, PEG-12 dimethicone, xanthan gum, imidazolidinyl urea, fragrance, methylparaben, sodium sulfate, propylparaben, sodium PCA, propylene glycol, anthemis nobilis flower extract, phenoxyethanol, sodium hyaluronate

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.
Questions Or Comments?   (Questions or comments?  )

1-800-950-4695

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation becomes severe.
Principal Display Panel 120 Ml Carton (PRINCIPAL DISPLAY PANEL - 120 mL CARTON)

proactiv®

CLEANSE

1

RENEWING

CLEANSER

4 FL. OZ. (120 mL)



benzoyl peroxide acne medication


Advanced Ingredient Data


Raw Label Data

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