Benzepro
FDA Label NDC 42546-015

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prugen, Inc. for the product Benzepro (NDC 42546-015). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use if you, when using this product, stop and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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
8714 E Vista Bonita Dr
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

Principal Display Panel (100 g Canister Box)

Principal Display Panel (100 g Canister Box)

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