BARE 40 SA- 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.

----------

BARE 40​​ SA 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, SALICYLIC ACID, CARBOMER, XANTHAN GUM, MINERAL OIL, PROPYLENE GLYCOL, EMULSIFIERS, TRIETHANOLAMINE, COCONUT OIL, PRESERVED WATER

KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

ENHANCED WITH GREEN TEA, ALOE VERA & TEA TREE OIL

MAXIMUM STRENGTH

VISIT US AT: SCISOLGLOBAL.COM

Packaging

image description

BARE 40 SA 
urea gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71718-003
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)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
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:71718-003-01113 g in 1 JAR; Type 0: Not a Combination Product08/01/2017
2NDC:71718-003-022 in 1 PACKAGE08/01/2017
2113 g in 1 JAR; Type 0: Not a Combination Product
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(71718-003)

Revised: 1/2018
Document Id: ac403f80-7a1e-4413-afa8-c6ba368f75e3
Set id: 9f162480-6e5d-4a7c-9da0-cccf7379b904
Version: 1
Effective Time: 20180117
 
Scientific Solutions Global, LLC