FDA.reportPublic FDA data

BPO 6%

Manufacturer
Acella Pharmaceuticals, LLC
Effective date
2018-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:54:58

Label at a glance#

ProductBPO 6%
Active ingredientBENZOYL PEROXIDE
Label structure9 sections

Dosage and administration

wash the affected area once or twice daily wet face with water wet cloth with a little water and work into a full lather cleanse face with cloth for 10 - 20 seconds, avoiding eyes and mucous membranes. rinse thoroughly and pat dry discard cloth, do not flush If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often If going outside, use a sunscreen. If irritation or sensitivity deve...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

6% Benzoyl Peroxide Acne Medication

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 6%

Purpose

OTC - PURPOSE SECTION

Acne Medication

Use

INDICATIONS & USAGE SECTION

treats acne 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 
  •  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

  • wash the affected area once or twice daily
  • wet face with water
  • wet cloth with a little water and work into a full lather
  • cleanse face with cloth for 10 - 20 seconds, avoiding eyes and mucous membranes.
  • rinse thoroughly and pat dry
  • discard cloth, do not flush
  • If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often
  • If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products 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

cetostearyl alcohol, cocamidopropyl betaine, corn starch, deionized water, dimethyl isosorbide, glycerine, glycolic acid, hydrogenated castor oil, imidurea, methylparaben, mineral oil, PEG-14M, potassium chloride, sodium hydroxide, sodium lauryl sulfate, sodium PCA and titanium dioxide.

Questions? 1-800-541-4802

Manufactured by:
Acella Pharmaceuticals, LLC
1-800-541-4802
Rev 1017-02

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42192-161-60

BPO 6% Foaming Cloths

6% Benzoyl Peroxide
Acne Medication

Net weight 3.2 g

Acella PHARMACEUTICALS, LLC

PRINCIPAL DISPLAY PANEL - label
PRINCIPAL DISPLAY PANEL - label

NDC 42192-161-60

BPO 6% Foaming Cloths

6% Benzoyl Peroxide
Acne Medication

60 foaming cloths • Net weight 3.2 g each

Acella PHARMACEUTICALS, LLC

PRINCIPAL DISPLAY PANEL - 60 Cloth Packet Carton
PRINCIPAL DISPLAY PANEL - 60 Cloth Packet Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-161-60EA - Each42192-1613c7e7564-f977-4687-930f-af634478fab312018-06-11

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42192-16142192-161-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
STARCH, CORNO8232NY3SJIACT
WATER059QF0KO0RIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
GLYCERINPDC6A3C0OXIACT
GLYCOLIC ACID0WT12SX38SIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
IMIDUREAM629807ATLIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE OXIDE 6000002126FD486LIACT
POTASSIUM CHLORIDE660YQ98I10IACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
61b7b789-0e10-4dd4-a2ce-cdb08916203c52b3826a-3b3d-4a13-9d18-4ff8882cc2bf2023-09-20WarningsExact identifier
spl set id: 52b3826a-3b3d-4a13-9d18-4ff8882cc2bf

Reported adverse events (FAERS/openFDA)#

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