BenzePrO Foam: Package Insert / Prescribing Information - Drugs.com

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# BenzePrO Foam

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

Medically reviewed by Drugs.com. Last updated on May 23, 2022.

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™ 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.

- 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

BENZEPRO benzoyl peroxide aerosol, foam

Product Information
Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC:42546-010
Route of Administration | TOPICAL | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) | BENZOYL PEROXIDE | 3.18 g in 60 g

Inactive Ingredients
Ingredient Name | Strength
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
Color | WHITE | Score |
Shape |  | Size |
Flavor |  | Imprint Code |
Contains |

Packaging
# | Item Code | Package Description
1 | NDC:42546-010-10 | 1 CAN in 1 BOX
1 |  | 100 g in 1 CAN
2 | NDC:42546-010-01 | 8 CANISTER in 1 CARTON
2 |  | 5 g in 1 CANISTER
3 | NDC:42546-010-06 | 1 CANISTER in 1 BOX
3 |  | 60 g in 1 CANISTER

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
OTC MONOGRAPH FINAL | part333D | 07/01/2012 |

Labeler - PruGen, Inc. (929922750)

Establishment
Name | Address | ID/FEI | Operations
PHARMASOL CORPORATION |  | 065144289 | MANUFACTURE(42546-010)

PruGen, Inc.

## Frequently asked questions

- Can you buy antibiotics over the counter?

## More about BenzePro (benzoyl peroxide topical)

- Check interactions
- Pricing & coupons
- Side effects
- Dosage information
- During pregnancy
- Drug class: topical acne agents
- Breastfeeding
- En español

### Patient resources

- Drug Information

### Professional resources

- Prescribing Information
- BenzePrO Foaming Cloths (FDA)
- BenzePrO Short Contact Foam (FDA)

#### Other brands

Epsolay, BPO 6 Foaming Cloths, Enzoclear Foam

### Related treatment guides

- Acne

Medical Disclaimer