Label: LACTIC ACID 10% / UREA 40% gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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 May 17, 2019

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  • Directions for use

    sd

  • Sincerus Flordia, LLC. Adverse reactions

    da

  • Active, Inactive

    asd

  • NDC 72934- 1135-4 LACTIC ACID 10% / UREA 40% . Gel 120gm

    zc

  • INGREDIENTS AND APPEARANCE
    LACTIC ACID 10% / UREA 40% 
    lactic acid 10% / urea 40% gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1135
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA40 g  in 100 g
    LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID10 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72934-1135-4120 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/17/2019
    Labeler - Sincerus Florida, LLC (080105003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sincerus Florida, LLC080105003manufacture(72934-1135)