Label: UREA 40- urea gel

  • NDC Code(s): 81376-211-01, 81376-211-03
  • Packager: SSG Ventures Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated April 7, 2021

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  • PRINCIPAL DISPLAY PANEL

    Label

    ACTIVE INGREDIENTS:

    UREA 40%

    SOOTHES ROUGH & DRY SKIN

    HEALS CORNS & CALLOUSES

    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.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

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

    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 
    urea gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81376-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA4 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Colorwhite (Opaque White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81376-211-01113 mL in 1 JAR; Type 0: Not a Combination Product04/01/2021
    2NDC:81376-211-03226 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2021
    Labeler - SSG Ventures Inc (047626115)
    Establishment
    NameAddressID/FEIBusiness Operations
    SSG Ventures Inc047626115manufacture(81376-211)