FDA Label for Benzepro
View Indications, Usage & Precautions
Benzepro Product Label
The following document was submitted to the FDA by the labeler of this product Prugen, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
8714 E Vista Bonita Dr
Scottsdale, AZ 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
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