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NDC 50268-0820-85 Urea 20 200 mg/g Details
Urea 20 200 mg/g
Urea 20 is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by AvPAK. The primary component is UREA.
Product Information
NDC | 50268-0820 |
---|---|
Product ID | 50268-820_e994fdc7-1d2e-1f1a-e053-2a95a90ae688 |
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 | Urea 20 |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Urea |
Product Type | HUMAN OTC DRUG |
Dosage Form | GEL |
Route | TOPICAL |
Active Ingredient Strength | 200 |
Active Ingredient Units | mg/g |
Substance Name | UREA |
Labeler Name | AvPAK |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | UNAPPROVED DRUG OTHER |
Application Number | n/a |
Listing Certified Through | 2023-12-31 |
Package
Package Images


NDC 50268-0820-85 (50268082085)
NDC Package Code | 50268-820-85 |
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Billing NDC | 50268082085 |
Package | 1 TUBE in 1 CARTON (50268-820-85) / 85 g in 1 TUBE |
Marketing Start Date | 2022-09-19 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e994fa05-a457-2555-e053-2a95a90ae83b Details
WARNINGS SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
UREA 20% Cream
FOR EXTERNAL USE ONLY.
Soothes, Softens and Moisturizes Dry Rough Skin
AvKARE
NET WT. 3 OZ. (85 g)
Manufactured for: AvKARE,
Pulaski, TN 38478
www.avkare.com
Questions or comments? 1-855-361-3993 AV 04/22

UREA 20% Cream
Product No. 50268-820-85
FOR EXTERNAL USE ONLY.
Soothes, Softens and Moisturizes Dry Rough Skin
AvKARE
NET WT. 3 OZ. (85 g)

INGREDIENTS AND APPEARANCE
UREA 20
urea gel |
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Labeler - AvPAK (832926666) |
Revised: 9/2022
Document Id: e994fdc7-1d2e-1f1a-e053-2a95a90ae688
Set id: e994fa05-a457-2555-e053-2a95a90ae83b
Version: 1
Effective Time: 20220926