Proactiv Solution Extra Strength Formula Lotion

Manufacturer
Guthy-Renker LLC
Effective date
2010-07-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:52:48

Label at a glance#

ProductProactiv Extra Strength Formula
Active ingredientBENZOYL PEROXIDE
Label structure9 sections

Dosage and administration

Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1 to 3 times daily. Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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, use a sunscreen.

Storage and handling

This product may bleach hair or dyed fabric. Store at room temperature. Avoid storing at extreme temperatures (below 40°F and above 100°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 7%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

For the management of acne

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

OTC - ASK DOCTOR SECTION

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • keep away from lips and mouth
  • avoid unnecessary sun exposure and use a sunscreen

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation becomes severe.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Cleanse the skin thoroughly before applying medication.
  • Cover the entire affected area with a thin layer 1 to 3 times daily.
  • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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, use a sunscreen.

Other information

STORAGE AND HANDLING SECTION

  • This product may bleach hair or dyed fabric.
  • Store at room temperature. Avoid storing at extreme temperatures (below 40°F and above 100°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water (aqua), cyclotetrasiloxane, ethoxydiglycol, propylene glycol, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, cyclopentasiloxane, panthenol, allantoin, carbomer, ceteareth-20, xanthan gum, triethanolamine, diazolidinyl urea, methylparaben, propylparaben, fragrance (parfum).

PRINCIPAL DISPLAY PANEL - 2 FL. OZ. 60 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rodan & Fields

proactiv ®
SOLUTION

EXTRA STRENGTH
FORMULA

lotion

3

benzoyl peroxide acne treatment

2 FL. OZ. 60 mL

PRINCIPAL DISPLAY PANEL - 2 FL. OZ. 60 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 2 FL. OZ. 60 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-30411410-304-10, 11410-304-23

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
43dbac64-554a-4c07-adf9-f94fe374029a5099ebef-0afe-4e99-a7e7-bb45b18ce6562010-07-13WarningsExact identifier
spl id: 43dbac64-554a-4c07-adf9-f94fe374029a
spl set id: 5099ebef-0afe-4e99-a7e7-bb45b18ce656

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.