Proactiv ®

Proactiv ®
SPL v4
SPL
SPL Set ID 822c64b9-59bd-4625-b4bf-294d54c96e10
Route
TOPICAL
Published
Effective Date 2022-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 g)
Inactive Ingredients
Water Dimethicone Cyclomethicone 5 Glycereth-26 Glycerin Cyclomethicone 6 Dimethiconol (40 Cst) Panthenol Green Tea Leaf Aloe Vera Leaf Shea Butter Levomenol Lactic Acid, Unspecified Form Caprylyl Glycol Ethylhexylglycerin Polyoxyl 40 Hydrogenated Castor Oil Polyisobutylene (1300 Mw) Hexylene Glycol Polysorbate 20 Ppg-26-buteth-26 Avobenzone Octinoxate Octisalate Phenoxyethanol Polyacrylamide (1300000 Mw) Peg-80 Sorbitan Laurate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-05-01

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.

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 uses. If no discomfort occurs, follow the directions stated below.

  • clean the skin thoroughly before applying this product 
  • 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

Salicylic acid 0.5%

Inactive Ingredients

water, dimethicone, cyclopentasiloxane, glycereth-26, glycerin, cyclohexasiloxane, PEG-80 sorbitan laurate, dimethiconol, polyacrylate-13, panthenol, phenoxyethanol, fragrance, polyisobutene, caprylyl glycol, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter, hexylene glycol, ethylhexylglycerin, bisabolol, lactic acid, polysorbate 20, ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, PPG-26-buteth-26, PEG-40 hydrogenated castor oil, ethylhexyl salicylate, camellia sinensis leaf extract

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 contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Principal Display Panel 30 Ml Tube Box

proactiv®

BLACKHEAD

DISSOLVING

GEL

1 FL. OZ. 30 mL

salicylic acid 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.

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 uses. If no discomfort occurs, follow the directions stated below.

  • clean the skin thoroughly before applying this product 
  • 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)

Salicylic acid 0.5%

Inactive Ingredients (Inactive ingredients)

water, dimethicone, cyclopentasiloxane, glycereth-26, glycerin, cyclohexasiloxane, PEG-80 sorbitan laurate, dimethiconol, polyacrylate-13, panthenol, phenoxyethanol, fragrance, polyisobutene, caprylyl glycol, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter, hexylene glycol, ethylhexylglycerin, bisabolol, lactic acid, polysorbate 20, ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, PPG-26-buteth-26, PEG-40 hydrogenated castor oil, ethylhexyl salicylate, camellia sinensis leaf extract

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 contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Principal Display Panel 30 Ml Tube Box (PRINCIPAL DISPLAY PANEL - 30 mL Tube Box)

proactiv®

BLACKHEAD

DISSOLVING

GEL

1 FL. OZ. 30 mL

salicylic acid acne medication


Advanced Ingredient Data


Raw Label Data

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