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NDC 45802-0216-01 benzoyl peroxide 5 g/100g Details
benzoyl peroxide 5 g/100g
benzoyl peroxide is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is BENZOYL PEROXIDE.
MedlinePlus Drug Summary
Benzoyl peroxide is used to treat mild to moderate acne.
Related Packages: 45802-0216-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
| NDC | 45802-0216 |
|---|---|
| Product ID | 45802-216_55454ffb-5ad4-4964-9de2-0490c124b116 |
| Associated GPIs | 90050010004010 |
| GCN Sequence Number | 005813 |
| GCN Sequence Number Description | benzoyl peroxide GEL (GRAM) 5 % TOPICAL |
| HIC3 | L5A |
| HIC3 Description | KERATOLYTICS |
| GCN | 22931 |
| 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 | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | g/100g |
| Substance Name | BENZOYL PEROXIDE |
| Labeler Name | Padagis Israel Pharmaceuticals Ltd |
| 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 45802-0216-01 (45802021601)
| NDC Package Code | 45802-216-01 |
|---|---|
| Billing NDC | 45802021601 |
| Package | 1 TUBE in 1 CARTON (45802-216-01) / 90 g in 1 TUBE |
| Marketing Start Date | 2012-04-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7441981a-654d-4f18-be21-66c863ee6d6f Details
Warnings
For external use only
When using this product
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- 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.
- •
- 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
- •
- 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.
Directions
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- Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
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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
- •
- 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, stop use of both products and ask a doctor.
Inactive ingredients
Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
| BENZOYL PEROXIDE
benzoyl peroxide gel |
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| Labeler - Padagis Israel Pharmaceuticals Ltd (600093611) |
Revised: 12/2021
Document Id: 55454ffb-5ad4-4964-9de2-0490c124b116
Set id: 7441981a-654d-4f18-be21-66c863ee6d6f
Version: 4
Effective Time: 20211214