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BenzePrO by PruGen, Inc.

Medically reviewed on June 20, 2018

Dosage form: aerosol, foam
Ingredients: BENZOYL PEROXIDE 9.8g in 100g
Labeler: PruGen, Inc.
NDC Code: 42546-015

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.

BenzePro Short Contact Foam

BenzePrO Short Contact Foam 

Drug Facts

Active ingredients

Benzoyl Peroxide 9.8%

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.

  • 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
  • Store at room temperature 15°-25° C (59°-77° F)
  • Protect from freezing
  • Store upright

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 Notrh Tompson Peak Parkway
Scottsdale, AZ 85255                                                 REV 1.2

PRINCIPAL DISPLAY PANEL - 100 g Canister Box

NDC 42546-015-10
Rx only

BenzePrO®

Short Contact Foam
benzoyl peroxide

9.8%

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

BENZEPRO 
benzoyl peroxide aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42546-015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE9.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
ALKYL (C12-15) BENZOATE 
CETOSTEARYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
DIMETHICONE 
EDETATE DISODIUM 
GLYCERIN 
METHYLPARABEN 
POVIDONE, UNSPECIFIED 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE, UNSPECIFIED FORM 
STEARETH-10 
STEARIC ACID 
TROLAMINE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:42546-015-101 CANISTER in 1 BOX
1100 g in 1 CANISTER
2NDC:42546-015-018 CANISTER in 1 CARTON
25 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D07/01/2012
Labeler - PruGen, Inc. (929922750)
Establishment
NameAddressID/FEIOperations
PHARMASOL CORPORATION065144289MANUFACTURE(42546-015)

 
PruGen, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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