BPO 8% Gel

Manufacturer
Acella Pharmaceuticals LLC
Effective date
2021-01-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:57:37

Label at a glance#

ProductBPO 8%
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 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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 8%

Purpose

OTC - PURPOSE SECTION

Acne Medication

Use

INDICATIONS & USAGE SECTION

Treats acnes and helps prevent new acne blemishes from forming.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

When using this product

OTC - WHEN USING SECTION

  • avoid unnecessary sun exposure and use sunscreen
  • keep away from eyes, lips and mouth
  • avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentrations may aggravate such irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration.
  • 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.

Stop use and ask a doctor if

OTC - STOP USE 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
  • 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, discontinue use of product and consult a doctor.

Other Information

SPL UNCLASSIFIED SECTION

Store at controlled room temperature 15˚ - 30˚C (59˚ - 86˚F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, benzyl alcohol, ceteareth-20, cetyl alcohol, dimethyl isosorbide, purified water, simethicone and stearyl alcohol.

Questions?

OTC - QUESTIONS SECTION

1-800-541-4802

Manufactured For:

Acella Pharmaceuticals, LLC
Alpharetta, GA 30005

Rev. 0718-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42192-163-15

BPO 8% Gel
(8% benzoyl peroxide acne medication)

For Topical Use

Net Wt. 42.5 g (1.5 oz)

Acella Pharmaceuticals, LLC

label-figure-01
label-figure-01

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-163-15GM - Gram42192-1639860d76a-7780-4fbe-a88c-5d2b65338d2612019-03-12

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42192-16342192-163-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
bfb11314-7e12-4022-bfec-d713ee26c31438df9a82-d8a7-4d04-b3f3-6c854ac786312023-09-20WarningsExact identifier
spl set id: 38df9a82-d8a7-4d04-b3f3-6c854ac78631

Reported adverse events (FAERS/openFDA)#

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