Benzoyl Peroxide Cleanser

Manufacturer
Pharmco Laboratories, Inc. | Pharmco Laboratories Inc.
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:44:18

Label at a glance#

ProductBenzoyl Peroxide Cleanser
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Indications and uses

For the treatment of acne.

Dosage and administration

Use once or twice daily. Morning and/or night. Apply to damp skin and Wash-In for up to 1 minute. Do not get in the eyes. For best results, use fingertips and apply to affected areas with gentle pressure in a circular motion. Rinse off with warm water and pat dry with soft towel. If going outside, apply broad spectrum sunscreen SPF 15 or higher.

Storage and handling

Store at 15 - 25°C (59 - 77°F) Protect from heat. Keep container tightly closed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 3.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne.

Warnings

WARNINGS SECTION

  • For external use only

Do not use if you

OTC - DO NOT USE SECTION

  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide

When using this product

OTC - WHEN USING SECTION

  • 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.
  • If going outside, apply sunscreen after using this product.

OTC - STOP USE SECTION

  • If sensitivity develops or irritation becomes severe, stop use and ask a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children
  • If swallowed get medical help or call a poison control center immediately

SPL UNCLASSIFIED SECTION

  • Keep away from excessive heat or heat sources

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use once or twice daily. Morning and/or night.
  • Apply to damp skin and Wash-In for up to 1 minute.
  • Do not get in the eyes.
  • For best results, use fingertips and apply to affected areas with gentle pressure in a circular motion.
  • Rinse off with warm water and pat dry with soft towel.
  • If going outside, apply broad spectrum sunscreen SPF 15 or higher.

Other Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, C12-14 Alkyl Olefin Sulfonate, Disodium Cocoamphodiacetate, Edetate Disodium, Ethylhexylglycerin, FD&C Yellow # 5, Glycerine, Panthenol, Perlite, Phenoxyethanol, Propylene Glycol, Sodium Hyaluronate, Sodium Hydroxide, Water

Other Information

STORAGE AND HANDLING SECTION

Store at 15 - 25°C (59 - 77°F) Protect from heat. Keep container tightly closed.

SPL UNCLASSIFIED SECTION

Manufactured by:
Pharmco Laboratories Inc. • Titusville, FL 32780

PRINCIPAL DISPLAY PANEL - 170 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARMCO
SKINCARE LABS

Benzoyl Peroxide
Cleansing Gel 3.5%

Net wt. 6 oz. (170 g)

PRINCIPAL DISPLAY PANEL - 170 g Bottle Label
PRINCIPAL DISPLAY PANEL - 170 g Bottle Label

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58400-00958400-009-01, 58400-009-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
3dd06c63-021d-41ad-b195-4c50d65bd6231a28b82b-e7da-428f-a9bf-68ef8d0db0702024-12-23WarningsExact identifier
spl id: 3dd06c63-021d-41ad-b195-4c50d65bd623
spl set id: 1a28b82b-e7da-428f-a9bf-68ef8d0db070

Reported adverse events (FAERS/openFDA)#

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