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NDC 67405-0830-05 Benzoyl Peroxide 100 mg/mL Details
Benzoyl Peroxide 100 mg/mL
Benzoyl Peroxide is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by HARRIS PHARMACEUTICAL, INC.. The primary component is BENZOYL PEROXIDE.
MedlinePlus Drug Summary
Benzoyl peroxide is used to treat mild to moderate acne.
Related Packages: 67405-0830-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
| NDC | 67405-0830 |
|---|---|
| Product ID | 67405-830_06ca5e12-1817-4719-ab81-707695bfccad |
| Associated GPIs | 90050010000910 |
| GCN Sequence Number | 059137 |
| GCN Sequence Number Description | benzoyl peroxide CLEANSER 10 % TOPICAL |
| HIC3 | L5A |
| HIC3 Description | KERATOLYTICS |
| GCN | 24673 |
| HICL Sequence Number | 002470 |
| HICL Sequence Number Description | BENZOYL PEROXIDE |
| Brand/Generic | Generic |
| Proprietary Name | Benzoyl Peroxide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Benzoyl Peroxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | TOPICAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/mL |
| Substance Name | BENZOYL PEROXIDE |
| Labeler Name | HARRIS PHARMACEUTICAL, INC. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333D |
| Listing Certified Through | n/a |
Package
Package Images
NDC 67405-0830-05 (67405083005)
| NDC Package Code | 67405-830-05 |
|---|---|
| Billing NDC | 67405083005 |
| Package | 148 mL in 1 BOTTLE (67405-830-05) |
| Marketing Start Date | 2011-11-18 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.04716 |
| Pricing Unit | GM |
| Effective Date | 2022-09-21 |
| NDC Description | BENZOYL PEROXIDE 10% WASH |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 98a495f6-367a-4acc-865e-e15c2e96d58b Details
Warnings
For external use only.
- Avoid contact with eyes, eyelids, lips and mucous membranes.
When using this product
- Avoid unnecessary sun exposure and use a sunscreen.
- Avoid contact with eyes, lips, and mouth.
- Avoid contact with hair or dyed fabrics, which may be bleached by this product.
- 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.
- 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
SHAKE WELL.
- Clean the skin thoroughly before applying this product.
- One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry.
- 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.
- Follow directions in the sunscreen labeling.
- If irritation or sensitivity develops stop use of both products and ask a doctor.
Inactive Ingredients
Carbomer interpolymer type A NF, cetyl alcohol NF, disodium oleamido MEA-sulfosuccinate, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 148 g Bottle Label
INGREDIENTS AND APPEARANCE
| BENZOYL PEROXIDE
benzoyl peroxide liquid |
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| Labeler - HARRIS PHARMACEUTICAL, INC. (617204370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Groupe PARIMA Inc. | 252437850 | manufacture(67405-830) | |
Revised: 7/2022
Document Id: 06ca5e12-1817-4719-ab81-707695bfccad
Set id: 98a495f6-367a-4acc-865e-e15c2e96d58b
Version: 3
Effective Time: 20220707