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NDC 00187-0201-10 BenzEFoam Ultra 9.8 g/100g Details
BenzEFoam Ultra 9.8 g/100g
BenzEFoam Ultra 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.
Product Information
NDC | 00187-0201 |
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Product ID | 0187-0201_adc4ed21-dfa8-4dad-8e03-e5f07fca03bc |
Associated GPIs | |
GCN Sequence Number | 003215 |
GCN Sequence Number Description | estrogens, conjugated TABLET 2.5 MG ORAL |
HIC3 | G1A |
HIC3 Description | ESTROGENIC AGENTS |
GCN | 10947 |
HICL Sequence Number | 001424 |
HICL Sequence Number Description | ESTROGENS, CONJUGATED |
Brand/Generic | Generic |
Proprietary Name | BenzEFoam Ultra |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | benzoyl peroxide |
Product Type | HUMAN OTC DRUG |
Dosage Form | AEROSOL |
Route | TOPICAL |
Active Ingredient Strength | 9.8 |
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 00187-0201-10 (00187020110)
NDC Package Code | 0187-0201-10 |
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Billing NDC | 00187020110 |
Package | 1 CAN in 1 CARTON (0187-0201-10) / 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 adc4ed21-dfa8-4dad-8e03-e5f07fca03bc 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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- rinse off after 2 minutes
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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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- to be used as a short contact application
Other Information
Inactive Ingredients
Package/Label Principal Display Panel - Carton
INGREDIENTS AND APPEARANCE
BENZEFOAM ULTRA
benzoyl peroxide aerosol |
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Labeler - Bausch Health US, LLC (831922468) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Denison Pharmaceuticals | 001207208 | MANUFACTURE(0187-0201) |
Revised: 2/2020
Document Id: adc4ed21-dfa8-4dad-8e03-e5f07fca03bc
Set id: adc4ed21-dfa8-4dad-8e03-e5f07fca03bc
Version: 1
Effective Time: 20200206