FDA.reportPublic FDA data

BenzePrO

Manufacturer
PruGen, Inc. | PHARMASOL CORPORATION
Effective date
2018-06-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 22:56:02

Label at a glance#

ProductBenzePrO
Active ingredientBENZOYL PEROXIDE
Label structure9 sections

Indications and uses

Indicated for the topical treatment of mild to moderate acne vulgaris

Dosage and administration

See package insert for full prescribing information Prime can before initial   use: See package insert Before Each Use: Shake vigorously During Use: Holding can upright, dispense into palm of hand and apply to affected area as directed by physician. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

BenzePrO™ Emollient Foam

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5.3%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

Indicated for the topical treatment of mild to moderate acne vulgaris

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

  • avoid unnecessary sun exposure and use a sunscreen 
  • avoid contact with 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, possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration

Stop 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

See package insert for full prescribing information

Prime can before initial use: See package insert Before Each Use: Shake vigorously

During Use: Holding can upright, dispense into palm of hand and apply to affected area as directed by physician.

  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information

SPL UNCLASSIFIED SECTION

  • 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, cetostearyl alcohol, citric acid, dimethicone, disodium EDTA, emulsifying wax, glycerin, methylparaben, povidone, propylene glycol, propylparaben, purified water, sodium citrate, steareth-10, stearic acid, trolamine. Also contains: Propellant HFA-134A (1, 1, 1, 2-tetrafluoroethane).

Questions? 866-696-8525

Manufactured for:
PruGen, Inc.
Pharmaceuticals
18899 North Thompson Peak Parkway
Scottsdale, Arizona 85255                                                 REV 1.2

PRINCIPAL DISPLAY PANEL - 100 g Can Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42546-010-10
Rx only

BenzePrO®

Emollient Foam
benzoyl peroxide
5.3%

For topical treatment
of mild to moderate
acne vulgaris

Net Weight 100 g

Will not dispense entire contents.
Container is overfilled to guarantee
dispensing at least the listed amount.

PRUGEN™
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 100 g Can Box
PRINCIPAL DISPLAY PANEL - 100 g Can Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1302433BenzePrO 5.3 % Topical FoamPSN8
866054benzoyl peroxide 5.3 % Topical FoamPSN8
1302433benzoyl peroxide 53 MG/ML Topical Foam [Benzepro]SBD8
866054benzoyl peroxide 53 MG/ML Topical FoamSCD8
1302433Benzepro 5.3 % Topical FoamSY8
866054benzoyl peroxide 5.3 % Topical FoamSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42546-010-012022-01-28C16284748780-1d6a99b39-ea13-a426-e053-dadaa90af4c2BenzePro Emollient Foam
42546-010-062022-01-28C16284748780-1d6a99b39-ea13-a426-e053-dadaa90af4c2BenzePro Emollient Foam
42546-010-102022-01-28C16284748780-1d6a99b39-ea13-a426-e053-dadaa90af4c2BenzePro Emollient Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-010-01BenzePrO5 g in 1 CANISTERAEROSOL, FOAM58
42546-010-01BenzePrO8 in 1 CARTONAEROSOL, FOAM88
42546-010-06BenzePrO1 in 1 BOXAEROSOL, FOAM18
42546-010-06BenzePrO60 g in 1 CANISTERAEROSOL, FOAM608
42546-010-10BenzePrO100 g in 1 CANAEROSOL, FOAM1008
42546-010-10BenzePrO1 in 1 BOXAEROSOL, FOAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-010BENZEPRO (BENZOYL PEROXIDE) AEROSOL, FOAM [PRUGEN, INC.]8Legacy NDC, 6 package rows20180621_890ed265-1217-4fa6-b7f1-a7246dbe137e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-010-06GM - Gram42546-0102b639973-3ffc-4a2f-bcd1-e71f8620435412013-02-13
42546-010-10GM - Gram42546-010cf81d733-17c3-45be-af9f-f701fcd3b26c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM4
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM4

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42546-01042546-010-10, 42546-010-01, 42546-010-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
STEARETH-10FD0913P475IACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT

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
42ff38ea-6810-4681-b0d4-ece33d6bd5fb890ed265-1217-4fa6-b7f1-a7246dbe137e2018-06-20WarningsExact identifier
spl id: 42ff38ea-6810-4681-b0d4-ece33d6bd5fb
spl set id: 890ed265-1217-4fa6-b7f1-a7246dbe137e

Reported adverse events (FAERS/openFDA)#

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