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BenzePrO Short Contact 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 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 Type HUMAN OTC DRUG Item Code (Source) NDC:42546-015
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 9.8 g in 100 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:42546-015-10 1 CANISTER in 1 BOX
1 100 g in 1 CANISTER
2 NDC:42546-015-01 8 CANISTER in 1 CARTON
2 5 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(42546-015)
PruGen, Inc.

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