BENZEPRO- benzoyl peroxide aerosol, foam 
PruGen, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BenzePro Emollient Foam

BenzePrO Emollient Foam

Drug Facts

Active ingredients

Benzoyl Peroxide 5.3%

Purpose

Acne Treatment

Uses

Indicated for the topical treatment of mild to moderate acne vulgaris

Warnings

For external use only

Do not use if you

  • have very sensitive skin
  • are sensitive to Benzoyl Peroxide

When using this product

  • 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

  • irritation becomes severe

Keep out of reach of children.

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

Directions

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.

Other Information

Inactive Ingredients

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

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
BENZEPRO 
benzoyl peroxide aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42546-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE3.18 g  in 60 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
STEARETH-10 (UNII: FD0913P475)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42546-010-101 in 1 BOX07/01/2012
1100 g in 1 CAN; Type 0: Not a Combination Product
2NDC:42546-010-018 in 1 CARTON07/01/2012
25 g in 1 CANISTER; Type 0: Not a Combination Product
3NDC:42546-010-061 in 1 BOX07/01/2012
360 g in 1 CANISTER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D07/01/2012
Labeler - PruGen, Inc. (929922750)
Establishment
NameAddressID/FEIBusiness Operations
PHARMASOL CORPORATION065144289MANUFACTURE(42546-010)

Revised: 6/2018
Document Id: 42ff38ea-6810-4681-b0d4-ece33d6bd5fb
Set id: 890ed265-1217-4fa6-b7f1-a7246dbe137e
Version: 8
Effective Time: 20180620
 
PruGen, Inc.