Search by Drug Name or NDC
NDC 42192-0161-60 BPO 6% 60 mg/1 Details
BPO 6% 60 mg/1
BPO 6% is a TOPICAL CLOTH 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: 42192-0161-60Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
| NDC | 42192-0161 |
|---|---|
| Product ID | 42192-161_34b6bc66-641a-4292-a942-758fda1774b6 |
| Associated GPIs | 90050010006375 |
| GCN Sequence Number | 064921 |
| GCN Sequence Number Description | benzoyl peroxide TOWELETTE 6 % TOPICAL |
| HIC3 | L5A |
| HIC3 Description | KERATOLYTICS |
| GCN | 17332 |
| HICL Sequence Number | 002470 |
| HICL Sequence Number Description | BENZOYL PEROXIDE |
| Brand/Generic | Generic |
| Proprietary Name | BPO 6% |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | BENZOYL PEROXIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CLOTH |
| Route | TOPICAL |
| Active Ingredient Strength | 60 |
| Active Ingredient Units | mg/1 |
| 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 42192-0161-60 (42192016160)
| NDC Package Code | 42192-161-60 |
|---|---|
| Billing NDC | 42192016160 |
| Package | 60 PACKET in 1 CARTON (42192-161-60) / 1 CLOTH in 1 PACKET |
| Marketing Start Date | 2018-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 52b3826a-3b3d-4a13-9d18-4ff8882cc2bf Details
Warnings
For external use only
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.
Directions
- wash the affected area once or twice daily
- wet face with water
- wet cloth with a little water and work into a full lather
- cleanse face with cloth for 10 - 20 seconds, avoiding eyes and mucous membranes.
- rinse thoroughly and pat dry
- discard cloth, do not flush
- If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often
- If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.
Inactive Ingredients
cetostearyl alcohol, cocamidopropyl betaine, corn starch, deionized water, dimethyl isosorbide, glycerine, glycolic acid, hydrogenated castor oil, imidurea, methylparaben, mineral oil, PEG-14M, potassium chloride, sodium hydroxide, sodium lauryl sulfate, sodium PCA and titanium dioxide.
Questions? 1-800-541-4802
Manufactured by:
Acella Pharmaceuticals, LLC
1-800-541-4802
Rev 1017-02
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| BPO 6%
benzoyl peroxide cloth |
||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||
| Labeler - Acella Pharmaceuticals, LLC (825380939) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Acella Pharmaceuticals, LLC | 825380939 | MANUFACTURE(42192-161) | |
Revised: 6/2018
Document Id: 34b6bc66-641a-4292-a942-758fda1774b6
Set id: 52b3826a-3b3d-4a13-9d18-4ff8882cc2bf
Version: 1
Effective Time: 20180604