Label: BENZEPRO- benzoyl peroxide aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 42546-015-01, 42546-015-10 - Packager: PruGen, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 20, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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Warnings
For external use only
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
- avoid unnecessary sun exposure and use a sunscreen
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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
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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
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INGREDIENTS AND APPEARANCE
BENZEPRO
benzoyl peroxide aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42546-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 9.8 g in 100 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:42546-015-10 1 in 1 BOX 07/01/2012 1 100 g in 1 CANISTER; Type 0: Not a Combination Product 2 NDC:42546-015-01 8 in 1 CARTON 07/01/2012 2 5 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(42546-015)
