Label: BARE 40 SA- urea gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 17, 2018

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  • ACTIVE INGREDIENTS:

    UREA

  • PURPOSE

    HEALS CORNS & CALLUSES

  • INDICATIONS & USAGE

    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

    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

  • STORAGE AND HANDLING

    KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

  • SPL UNCLASSIFIED SECTION

    ENHANCED WITH GREEN TEA, ALOE VERA & TEA TREE OIL

    MAXIMUM STRENGTH

    VISIT US AT: SCISOLGLOBAL.COM

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    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)
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