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NDC 42192-0163-15 BPO 8% 8 mg/100mg Details
BPO 8% 8 mg/100mg
BPO 8% is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Acella Pharmaceuticals LLC. The primary component is BENZOYL PEROXIDE.
MedlinePlus Drug Summary
Benzoyl peroxide is used to treat mild to moderate acne.
Related Packages: 42192-0163-15Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
NDC | 42192-0163 |
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Product ID | 42192-163_b8545e47-bdc7-37a5-e053-2995a90a0b87 |
Associated GPIs | 90050010004014 |
GCN Sequence Number | 021967 |
GCN Sequence Number Description | benzoyl peroxide GEL (GRAM) 8 % TOPICAL |
HIC3 | L5A |
HIC3 Description | KERATOLYTICS |
GCN | 22936 |
HICL Sequence Number | 002470 |
HICL Sequence Number Description | BENZOYL PEROXIDE |
Brand/Generic | Generic |
Proprietary Name | BPO 8% |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Benzoyl Peroxide |
Product Type | HUMAN OTC DRUG |
Dosage Form | GEL |
Route | TOPICAL |
Active Ingredient Strength | 8 |
Active Ingredient Units | mg/100mg |
Substance Name | BENZOYL PEROXIDE |
Labeler Name | Acella Pharmaceuticals LLC |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part333D |
Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 42192-0163-15 (42192016315)
NDC Package Code | 42192-163-15 |
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Billing NDC | 42192016315 |
Package | 42500 mg in 1 TUBE (42192-163-15) |
Marketing Start Date | 2019-01-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 38df9a82-d8a7-4d04-b3f3-6c854ac78631 Details
When using this product
- avoid unnecessary sun exposure and use sunscreen
- keep away from eyes, lips and mouth
- avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentrations may aggravate such irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration.
- skin irritation and dryness is 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.
KEEP OUT OF REACH OF CHILDREN
Directions
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to three times daily
- 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
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, discontinue use of product and consult a doctor.
Inactive Ingredients
Questions?
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
BPO 8%
benzoyl peroxide gel |
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Labeler - Acella Pharmaceuticals LLC (825380939) |
Revised: 1/2021
Document Id: b8545e47-bdc7-37a5-e053-2995a90a0b87
Set id: 38df9a82-d8a7-4d04-b3f3-6c854ac78631
Version: 6
Effective Time: 20210107