BENZEPRO- benzoyl peroxide aerosol, foam

BenzePrO by

Drug Labeling and Warnings

BenzePrO by is a Otc medication manufactured, distributed, or labeled by PruGen, Inc., PHARMASOL CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BENZEPRO 
benzoyl peroxide aerosol, foam

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	3.18 g  in 60 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42546-010-10	1 in 1 BOX	07/01/2012
1		100 g in 1 CAN; Type 0: Not a Combination Product
2	NDC: 42546-010-01	8 in 1 CARTON	07/01/2012
2		5 g in 1 CANISTER; Type 0: Not a Combination Product
3	NDC: 42546-010-06	1 in 1 BOX	07/01/2012
3		60 g in 1 CANISTER; Type 0: Not a Combination Product

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	Business Operations
PHARMASOL CORPORATION		065144289	MANUFACTURE(42546-010)