Proactiv ®

Proactiv ®
SPL v4
SPL
SPL Set ID 380d0f8f-8d31-41b9-9d5f-8a35f7f81b5b
Route
TOPICAL
Published
Effective Date 2022-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (3 g)
Inactive Ingredients
Water Sodium Cocoyl Isethionate Coco Glucoside Coconut Acid Coconut Alcohol Glycereth-18 Ethylhexanoate Glycereth-18 Docosanol Titanium Dioxide Phenoxyethanol Sodium Isethionate Sodium Hydroxide Arachidyl Alcohol Stearyl Alcohol Xanthan Gum Ethylhexylglycerin Glycerin Tetrasodium Glutamate Diacetate Matricaria Chamomilla

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-15

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 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.
  • apply only to areas with acne.
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Section 50570-1

Do not useon

  • broken skin
  • large areas of the skin.
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, follows the directions stated below.
  • cover the entire affected area with a thin layer and rinse thoroughly 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.
Active Ingredient

Sulfur 3%

Inactive Ingredients

water, sodium cocoyl isethionate, coco-glucoside, acrylates copolymer, coconut acid, coconut alcohol, glycereth-18 ethylhexanoate, glycereth-18, behenyl alcohol, titanium dioxide (CI 77891), phenoxyethanol, sodium isethionate, sodium hydroxide, arachidyl alcohol, stearyl alcohol, xanthan gum, ethylhexylglycerin, glycerin, tetrasodium glutamate diacetate, chamomilla recumta (matricaria) flower extract

Questions Or Comments?

Within US 1-800-950-4695

Principal Display Panel  6 Fl. Oz. (177.4 Ml)

proactivclean TM                         

Mineral

Acne Cleanser




sulfur acne medication



Both treats and helps

prevent breakouts

                


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 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.
  • apply only to areas with acne.
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Section 50570-1 (50570-1)

Do not useon

  • broken skin
  • large areas of the skin.
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, follows the directions stated below.
  • cover the entire affected area with a thin layer and rinse thoroughly 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.
Active Ingredient (Active ingredient)

Sulfur 3%

Inactive Ingredients (Inactive ingredients)

water, sodium cocoyl isethionate, coco-glucoside, acrylates copolymer, coconut acid, coconut alcohol, glycereth-18 ethylhexanoate, glycereth-18, behenyl alcohol, titanium dioxide (CI 77891), phenoxyethanol, sodium isethionate, sodium hydroxide, arachidyl alcohol, stearyl alcohol, xanthan gum, ethylhexylglycerin, glycerin, tetrasodium glutamate diacetate, chamomilla recumta (matricaria) flower extract

Questions Or Comments? (Questions or comments?)

Within US 1-800-950-4695

Principal Display Panel  6 Fl. Oz. (177.4 Ml) (PRINCIPAL DISPLAY PANEL - 6 FL. OZ. (177.4 mL))

proactivclean TM                         

Mineral

Acne Cleanser




sulfur acne medication



Both treats and helps

prevent breakouts

                


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)