Label: UREA 40 PLUS HA- urea gel

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

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Drug Label Information

Updated September 27, 2019

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  • PRINCIPAL DISPLAY PANEL

    UreaHA

    ACTIVE INGREDIENTS:

    UREA

    SOOTHES ROUGH & DRY SKIN

    HEALS CORNS & CALLOUSES

    SOFTENS NAILS

    SOOTHES ROUGH & DRY SKIN

    FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES.

    KEEP OUT OF REACH OF CHILDREN. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

    KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

    KEEP OUT OF REACH OF CHILDREN.

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

    ALOE VERA, CARBOMER, COCONUT OIL, EMULSIFIERS, GREEN TEA, MINERAL OIL, PRESERVED WATER, POPYLENE GLYCOL, SODIUM HYALURONATE, TEA TREE OIL, TRIETHANOLOAMINE, XANTHAM GUM

    KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

    ENHANCED WITH TEA TREE OIL & ALOE VERA

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

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

  • INGREDIENTS AND APPEARANCE
    UREA 40 PLUS HA 
    urea gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71718-213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA40 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECETH-10 (UNII: G624N6MSBA)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Product Characteristics
    Colorwhite (Opaque White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71718-213-01113 g in 1 JAR; Type 0: Not a Combination Product09/20/2019
    2NDC:71718-213-02113 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/20/2019
    3NDC:71718-213-03226 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/20/2019
    Labeler - Scientific Solutions Global LLC (097291290)
    Establishment
    NameAddressID/FEIBusiness Operations
    Scientific Solutions Global LLC097291290manufacture(71718-213)
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