Label: UREA 40 NAIL GEL- urea gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 81376-600-01 - Packager: SSG Ventures Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated February 9, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
PRINCIPAL DISPLAY PANEL
WITH THE POWER OF UREA, THIS NAIL GEL REDUCES NAIL THICKNEDD AND PROTECTS THE NAIL FROM FUNGAL GROWTH WHILE CLEARING THE REMNANTS FROM THE NAIL BED.
SMOOTHS ANS EXFOLIATES NAILS.
SUITABLE FOR FINGERNAILS AND TOENAILS.
-
INGREDIENTS AND APPEARANCE
UREA 40 NAIL GEL
urea gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81376-600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 12 g in 12 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHYL SULFOXIDE (UNII: YOW8V9698H) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) Product Characteristics Color white (clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81376-600-01 30 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 10/07/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/07/2019 Labeler - SSG Ventures Inc (047626115) Establishment Name Address ID/FEI Business Operations SSG Ventures Inc 047626115 manufacture(81376-600)