Proactiv ®

Proactiv ®
SPL v11
SPL
SPL Set ID 9bbf6db0-ff80-44d2-b81b-40080ca46b92
Route
TOPICAL
Published
Effective Date 2022-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (2.5 mg)
Inactive Ingredients
Water Diethylene Glycol Monoethyl Ether Cyclomethicone 5 Propylene Glycol Cetostearyl Alcohol Dimethicone Glyceryl Monostearate Peg-100 Stearate Panthenol Allantoin Xanthan Gum Polyoxyl 20 Cetostearyl Ether Diazolidinyl Urea Methylparaben Propylparaben Sodium Hydroxide Carbomer Homopolymer, Unspecified Type

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-11-01

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 50566-9

Stop use and ask a doctor if

▪  skin irritation becomes severe.

Section 50567-7

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.

Do notuse if 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.
  • cleanse the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer one 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, ethoxydiglycol, cyclopentasiloxane, propylene glycol, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, ceteareth-20, diazolidinyl urea, carbomer, fragrance, methylparaben,  xanthan gum,  panthenol, allantoin,, sodium hydroxide, propylparaben

Questions or comments?  1-800-950-4695

 

Principal Display Panel 60 Ml Carton

2 FL. OZ. (60 mL)


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 50566-9 (50566-9)

Stop use and ask a doctor if

▪  skin irritation becomes severe.

Section 50567-7 (50567-7)

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.

Do notuse if 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.
  • cleanse the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer one 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, ethoxydiglycol, cyclopentasiloxane, propylene glycol, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, ceteareth-20, diazolidinyl urea, carbomer, fragrance, methylparaben,  xanthan gum,  panthenol, allantoin,, sodium hydroxide, propylparaben

Questions or comments?  1-800-950-4695

 

Principal Display Panel 60 Ml Carton (PRINCIPAL DISPLAY PANEL - 60 mL Carton)

2 FL. OZ. (60 mL)


Advanced Ingredient Data


Raw Label Data

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