Search by Drug Name or NDC
NDC 61924-0092-01 DERMAKLEEN 0.002 g/mL Details
DERMAKLEEN 0.002 g/mL
DERMAKLEEN is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by Dermarite Industries LLC. The primary component is CHLOROXYLENOL.
Product Information
NDC | 61924-0092 |
---|---|
Product ID | 61924-092_d57e4b6c-0b21-7ab2-e053-2995a90a77e4 |
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 | DERMAKLEEN |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | ANTIMICROBIAL DRUG PRODUCT |
Product Type | HUMAN OTC DRUG |
Dosage Form | SOAP |
Route | TOPICAL |
Active Ingredient Strength | 0.002 |
Active Ingredient Units | g/mL |
Substance Name | CHLOROXYLENOL |
Labeler Name | Dermarite Industries LLC |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part333A |
Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 61924-0092-01 (61924009201)
NDC Package Code | 61924-092-01 |
---|---|
Billing NDC | 61924009201 |
Package | 3800 mL in 1 JUG (61924-092-01) |
Marketing Start Date | 2012-06-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ff28985e-d941-4350-971f-fdc2dbbb93bb Details
Warnings
Warnings
Directions:
Inactive Ingredients:
Cocamide MEA, Cocamidoproplyl Betaine, Citric Acid, DMDM Hydantoin, D&C Green#6, Fragrance, Glycerin, Methylchloroisothiazolinone, Methylparaben, Methylisothiazolinone, Propylene Glycol, Propylparaben, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Tocopheryl Acetate, Water.
INGREDIENTS AND APPEARANCE
DERMAKLEEN
antimicrobial drug product soap |
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
Labeler - Dermarite Industries LLC (883925562) |
Registrant - DermaRite Industries, LLC (883925562) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Dermarite Industries LLC | 883925562 | manufacture(61924-092) |
Revised: 1/2022
Document Id: d57e4b6c-0b21-7ab2-e053-2995a90a77e4
Set id: ff28985e-d941-4350-971f-fdc2dbbb93bb
Version: 10
Effective Time: 20220113