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BenzePrO Foam Prescribing Information

Package insert / product label
Generic name: benzoyl peroxide
Dosage form: aerosol, foam
Drug class: Topical acne agents

Medically reviewed by Drugs.com. Last updated on Feb 28, 2024.

BenzePrO Emollient Foam

Drug Facts

Active ingredients

Benzoyl Peroxide 5.3%

Purpose

Acne Treatment

Indications and Usage for BenzePrO Foam

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.

BenzePrO Foam 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.

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 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)

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