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NDC 00187-0194-10 BenzEFoam 5.3 g/100g Details
BenzEFoam 5.3 g/100g
BenzEFoam is a TOPICAL AEROSOL in the HUMAN OTC DRUG category. It is labeled and distributed by Bausch Health US, LLC. The primary component is BENZOYL PEROXIDE.
MedlinePlus Drug Summary
Benzoyl peroxide is used to treat mild to moderate acne.
Related Packages: 00187-0194-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
NDC | 00187-0194 |
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Product ID | 0187-0194_225799d1-e616-45e8-8074-6fa232b42cc9 |
Associated GPIs | 90050010003930 |
GCN Sequence Number | 065589 |
GCN Sequence Number Description | benzoyl peroxide FOAM 5.3% TOPICAL |
HIC3 | L5A |
HIC3 Description | KERATOLYTICS |
GCN | 27596 |
HICL Sequence Number | 002470 |
HICL Sequence Number Description | BENZOYL PEROXIDE |
Brand/Generic | Brand |
Proprietary Name | BenzEFoam |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | benzoyl peroxide |
Product Type | HUMAN OTC DRUG |
Dosage Form | AEROSOL |
Route | TOPICAL |
Active Ingredient Strength | 5.3 |
Active Ingredient Units | g/100g |
Substance Name | BENZOYL PEROXIDE |
Labeler Name | Bausch Health US, LLC |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part333D |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 00187-0194-10 (00187019410)
NDC Package Code | 0187-0194-10 |
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Billing NDC | 00187019410 |
Package | 1 CAN in 1 CARTON (0187-0194-10) / 100 g in 1 CAN |
Marketing Start Date | 2020-02-06 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 225799d1-e616-45e8-8074-6fa232b42cc9 Details
When using this product
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- skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
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- avoid unnecessary sun exposure and use a sunscreen.
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- avoid contact with the eyes, lips, and mouth.
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- avoid contact with hair and dyed fabrics, which may be bleached by this product.
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- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
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- do not puncture or incinerate container. Contents under pressure.
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- do not expose to temperatures above 120°F (49°C).
Keep Out of Reach of Children
Directions
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- clean the skin thoroughly before applying this product
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- cover the entire affected area with a thin layer one to three times daily
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- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
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- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
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- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
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- can be used as either a leave-on or short contact application
Other Information
Inactive Ingredients
Package/Label Principal Display Panel - Carton
NDC: 0187-0194-10
BenzEFoam
Emollient Foam
benzoyl peroxide 5.3%
Acne Treatment
Emollient Foam
For Topical Use Only
Do Not Use in Eyes
Will not dispense entire contents.
Container is overfilled to guarantee
dispensing a minimum of 100 grams.
Back Applicator Included
Ortho Dermatologics
Net Wt 3.5 OZ (100 g)
INGREDIENTS AND APPEARANCE
BENZEFOAM
benzoyl peroxide aerosol |
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Labeler - Bausch Health US, LLC (831922468) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Denison Pharmaceuticals | 001207208 | MANUFACTURE(0187-0194) |
Revised: 2/2020
Document Id: 225799d1-e616-45e8-8074-6fa232b42cc9
Set id: 225799d1-e616-45e8-8074-6fa232b42cc9
Version: 1
Effective Time: 20200206