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NDC 39765-0034-01 24 Hour Acne Serum 5 g/100g Details
24 Hour Acne Serum 5 g/100g
24 Hour Acne Serum is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Neutraderm, Inc.. The primary component is BENZOYL PEROXIDE.
MedlinePlus Drug Summary
Benzoyl peroxide is used to treat mild to moderate acne.
Related Packages: 39765-0034-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benzoyl Peroxide Topical
Product Information
| NDC | 39765-0034 |
|---|---|
| Product ID | 39765-034_21c73db5-9dd9-4805-b894-11ce10ad31ae |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | 24 Hour Acne Serum |
| 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 | Neutraderm, Inc. |
| 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 39765-0034-01 (39765003401)
| NDC Package Code | 39765-034-01 |
|---|---|
| Billing NDC | 39765003401 |
| Package | 32 g in 1 BOTTLE (39765-034-01) |
| Marketing Start Date | 2019-02-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e9f99e09-a195-481b-a178-36eba74dc330 Details
Warnings
For external use only.
When using this product • avoid unnecessary sun exposure and use sunscreen. • avoid contact with eyes, lips and mouth. • avoid contact with hair and dyed products, 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
• Clean the skin thoroughly before applying this product. Apply affected area with a thin layer, avoiding eye area. Allow to absorb before applying additional products. Can be used twice daily or as directed by physician. If irritation or sensitivity develops, stop use of product and consult physician.
Inactive Ingredients
Water, Glycolic Acid, Sclerotium Gum, Arnica Montana Flower Extract, Allantoin, Echinacea Purpurea Extract, Hydrastis Canadensis (Goldenseal) Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Calendula Officinalis Flower Extract, Glycerin, Gluconolactone, Sodium Benzoate, Tetrasodium EDTA, Sodium Hydroxide
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| 24 HOUR ACNE SERUM
benzoyl peroxide gel |
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| Labeler - Neutraderm, Inc. (146224444) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Neutraderm, Inc. | 146224444 | manufacture(39765-034) | |