BARE 40- urea gel 
Scientific Solutions Global, LLC

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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BARE 40 urea gel

ACTIVE INGREDIENTS:

UREA

HEALS CORNS & CALLUSES

SOOTHES ROUGH & DRY SKIN

SOFTEN NAILS

MOISTURIZING GEL

SAFETY WARNING :

FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES.

STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

KEEP OUT OF REACH OF CHILDREN. 

DIRECTIONS:

APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.

USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

INACTIVE INGREDIENTS :

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

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

ENHANCED WITH ALOE VERA & TEA TREE OIL

MAXIMUM STRENGTH

VISIT US AT : UREAEVERYTHING.COM

PACKAGING:

BARE40 UREA GEL

BARE 40 
urea gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71718-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA40 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
COCONUT OIL (UNII: Q9L0O73W7L)  
WATER (UNII: 059QF0KO0R)  
TRIDECETH-10 (UNII: G624N6MSBA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71718-002-01113 g in 1 JAR; Type 0: Not a Combination Product08/01/2017
2NDC:71718-002-022 in 1 PACKAGE08/01/2017
2113 g in 1 JAR; Type 0: Not a Combination Product
3NDC:71718-002-03226 g in 1 TUBE; Type 0: Not a Combination Product03/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/2017
Labeler - Scientific Solutions Global, LLC (097291290)
Establishment
NameAddressID/FEIBusiness Operations
Scientific Solutions Global, LLC097291290manufacture(71718-002)

Revised: 3/2018
Document Id: a66b9eda-7266-4c8f-839e-4de0499ac960
Set id: 9c1199ae-c932-4291-b512-c263b9b8f968
Version: 2
Effective Time: 20180322
 
Scientific Solutions Global, LLC