UREA 20- urea gel 
SSG Ventures Inc

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.

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Urea 20

Label

Inactive Ingredients

PRESERVED WATER, MINERAL OIL, PROPYLENE GLYCOL, TRIETHANOLAMINE, COCONUT OIL, EMULTHIX, CARBOMER, XANTHAN GUM, TEA TREE OIL, ALOE VERA, METHYLPARABEN, PROPYLPARABEN

Inactive Ingredients

CARBOMER, XANTHAN GUM, MINERAL OIL, PROPYLENE
GLYCOL, EMULSIFIERS, TRIETHANOLOAMINE

Directions

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR
AS NEEDED. USE CONTINUOUSLY FOR 2-3 WEEKS FOR
OPTIMAL RESULTS.

Active Ingredients

UREA 20%

DIRECTIONS:

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

Indications:

SOOTHES ROUGH & DRY SKINSOFTEN NAILSMOISTURIZING GEL

KEEP OUT OF REACH OF CHILDREN.

UREA

REDUCES CORNS & CALLUSES

SAFETY WARNING :

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES.STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

UREA 20 
urea gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81376-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MINERAL OIL (UNII: T5L8T28FGP)  
COCONUT OIL (UNII: Q9L0O73W7L)  
WATER (UNII: 059QF0KO0R)  
TEA TREE OIL (UNII: VIF565UC2G)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Product Characteristics
Colorwhite (Opaque White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81376-210-08113 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/20/2019
Labeler - SSG Ventures Inc (047626115)
Establishment
NameAddressID/FEIBusiness Operations
SSG Ventures Inc047626115manufacture(81376-210)

Revised: 4/2021
Document Id: bf66d0de-71da-1817-e053-2a95a90a08d9
Set id: b7112eb7-2ec1-8b17-e053-2995a90a4e1b
Version: 2
Effective Time: 20210407
 
SSG Ventures Inc