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

Purpose

Acne treatment

Description

Drug Facts


Medication Information

Warnings

For external use only

Purpose

Acne treatment

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.
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

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
Active Ingredient

Benzoyl peroxide 2.5%

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

Warnings

For external use only

Purpose

Acne treatment

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.
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

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
Active Ingredient (Active ingredient)

Benzoyl peroxide 2.5%

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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