Proactiv+ Skin Smoothing Exfoliator

Proactiv+ Skin Smoothing Exfoliator
SPL v10
SPL
SPL Set ID b56b63d6-5635-4fd4-9517-8b08c3cbf9aa
Route
TOPICAL
Published
Effective Date 2022-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (2.5 mg)
Inactive Ingredients
Water Sodium Cocoyl Isethionate Glycerin Lauryl/myristyl Benzoate Coconut Acid Linoleic Acid Linolenic Acid Butylene Glycol Dimethicone Ethylhexylglycerin Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Glycolic Acid Sodium Isethionate Sodium Hydroxide Phenoxyethanol Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-01-25

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, sodium cocoyl isethionate, glycerin, paraffin, lauryl/myristyl benzoate, coconut acid, butylene glycol, acrylates/C10-30 alkyl acrylate crosspolymer, phenoxyethanol, sodium isethionate, sodium hydroxide, fragrance, dimethicone, linoleic acid, ethylhexylglycerin, glycolic acid, linolenic acid

Questions Or Comments?

1-800-950-4695

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 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
  • irritation becomes severe.
Principal Display Panel 60 Ml Carton

proactiv +

Skin

Smoothing

Exfoliator

2 FL. OZ. (60 mL)

benzoyl peroxide

acne treatment


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, sodium cocoyl isethionate, glycerin, paraffin, lauryl/myristyl benzoate, coconut acid, butylene glycol, acrylates/C10-30 alkyl acrylate crosspolymer, phenoxyethanol, sodium isethionate, sodium hydroxide, fragrance, dimethicone, linoleic acid, ethylhexylglycerin, glycolic acid, linolenic acid

Questions Or Comments? (Questions or comments?)

1-800-950-4695

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 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)
  • irritation becomes severe.
Principal Display Panel 60 Ml Carton (PRINCIPAL DISPLAY PANEL - 60 mL Carton)

proactiv +

Skin

Smoothing

Exfoliator

2 FL. OZ. (60 mL)

benzoyl peroxide

acne treatment


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)