BenzEFoam Ultra

Manufacturer
Bausch Health US, LLC | Denison Pharmaceuticals
Effective date
2020-02-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:40:33

Label at a glance#

ProductBenzEFoam Ultra
Active ingredientBENZOYL PEROXIDE
Label structure13 sections

Dosage and administration

▪ clean the skin thoroughly before applying this product ▪ cover the entire affected area with a thin layer one to three times daily ▪ rinse off after 2 minutes ▪ 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 ever...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide (9.8%)

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only

Do not use if you

SPL UNCLASSIFIED SECTION

■ have very sensitive skin

■ are sensitive to benzoyl peroxide

When using this product

SPL UNCLASSIFIED SECTION

  • skin irritation and dryness are 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 not puncture or incinerate container. Contents under pressure.
  • do not expose to temperatures above 120°F (49°C).

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

■ irritation becomes severe

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • rinse off after 2 minutes
  • 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
  • to be used as a short contact application

Other Information

OTHER SAFETY INFORMATION

■ store at room temperature 15°-25°C (59°-77°F). Protect from freezing. Store upright.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

BHT, C12-15 alkyl benzoate, cetearyl alcohol, citric acid, dimethicone, disodium EDTA, emulsifying wax, glycerin, hydrofluorocarbon 134a, methylparaben, propylene glycol, propylparaben, purified water,

sodium citrate, steareth-10

Questions/comments?

OTC - QUESTIONS SECTION

Call: 1-800-321-4576

Package/Label Principal Display Panel - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 0187-0194-10

BenzEFoam Ultra

benzoyl peroxide 9.8%

Acne Treatment
Short Contact Foam

For Topical Use Only
Do Not Use in Eyes

Will not dispense entire contents.
Container is overfilled to guarantee
dispensing a minimum of 100 grams.

Back Applicator Included

Ortho Dermatologics

Net Wt 3.5 OZ (100 g)

carton.jpgcarton.jpg

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0187-02010187-0201-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML · Source PDF

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
c89a6e7e-f211-49d1-b5db-d64e8ad0cf80adc4ed21-dfa8-4dad-8e03-e5f07fca03bc2020-02-06WarningsExact identifier
spl set id: adc4ed21-dfa8-4dad-8e03-e5f07fca03bc

Reported adverse events (FAERS/openFDA)#

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