Micronized BPO Wash

Manufacturer
Pharmco Laboratories, Inc. | Pharmco Laboratories Inc.
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:44:29

Label at a glance#

ProductMicronized BPO Wash
Active ingredientBENZOYL PEROXIDE
Label structure9 sections

Dosage and administration

Apply a quarter-sized amount to damp skin with gentle pressure and work into lather. Rinse with lukewarm water and pat dry with soft towel. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily or as directed by a physician or skincare professional. If bothersome dryness or peeling occurs, reduce frequency of applications. If going out...

Storage and handling

Store at 20 - 25°C (68 - 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 5%

INDICATIONS & USAGE SECTION

Purpose

OTC - PURPOSE SECTION

Acne Treatment

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

Apply a quarter-sized amount to damp skin with gentle pressure and work into lather. Rinse with lukewarm water and pat dry with soft towel. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily or as directed by a physician or skincare professional. If bothersome dryness or peeling occurs, reduce frequency of applications. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use and consult a physician or skin care professional.

Other Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, C12-14 Alkyl Olefin Sulfonate, Disodium Cocoamphodiacetate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Panthenol, Phenoxyethanol, Polyethylene, Propylene Glycol, Sodium Hyaluronate, Sodium Hydroxide.

Other Information

STORAGE AND HANDLING SECTION

Store at 20 - 25°C (68 - 77°F) Protect from heat. Keep container tightly closed.

SPL UNCLASSIFIED SECTION

Manufactured by:
Pharmco Laboratories Inc. • Titusville, FL 32780
www.pharmcolabs.com • 1.800.635.0712 • Reorder CPL02

PRINCIPAL DISPLAY PANEL - 3.9 kg Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARMCO
SKINCARE LABS

Micronized
BPO 5%
WASH

Net wt. 3.9 kg

Principal Display Panel - 3.9 kg Bottle Label
Principal Display Panel - 3.9 kg Bottle Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GM1
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GM1
AllantoinINACTIVE INGREDIENT344S277G0Z1
Disodium CocoamphodiacetateINACTIVE INGREDIENT18L9G3U51M1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
EthylhexylglycerinINACTIVE INGREDIENT147D247K3P1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Hyaluronate SodiumINACTIVE INGREDIENTYSE9PPT4TH1
PanthenolINACTIVE INGREDIENTWV9CM0O67Z1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58400-00458400-004-01, 58400-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 420 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / URETERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAMUSCULAR176 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KPOWDER, FOR SUSPENSION / ORAL285 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, FILM COATED / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISPONGE / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ITABLET, FILM COATED / ORAL8 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVASCULAR0.48 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / ORAL400 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / TRANSDERMAL472 mgExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, EMULSION / INTRAVENOUS59 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / EXTRACORPOREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVENOUS456 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-AMNIOTICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTERSTITIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IFILM / BUCCAL0.09 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ITABLET, COATED / ORALNAExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IJELLY / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATUMORADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates

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
619aa0f6-8fbf-4b3b-91db-7e00cc7da4bcfe1f2ccf-0181-4615-8f65-ae0541502ff32024-12-23WarningsExact identifier
spl id: 619aa0f6-8fbf-4b3b-91db-7e00cc7da4bc
spl set id: fe1f2ccf-0181-4615-8f65-ae0541502ff3

Reported adverse events (FAERS/openFDA)#

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