Label: UREA 20- urea gel
- NDC Code(s): 50268-820-85
- Packager: AvPAK
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated March 6, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS SECTION
- KEEP OUT OF REACH OF CHILDREN
- DO NOT USE
- WHEN USING
- STOP USE
- DOSAGE & ADMINISTRATION
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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 04/22UREA 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 gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50268-820 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 200 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TRIACETIN (UNII: XHX3C3X673) WHITE PETROLATUM (UNII: B6E5W8RQJ4) Product Characteristics Color white (Opaque White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50268-820-85 1 in 1 CARTON 09/19/2022 1 85 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/19/2022 Labeler - AvPAK (832926666)