Label: YOWCH EXTRA STRENGTH FOR MINOR BURNS- lidocaine hcl cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 20, 2015

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  • DOSAGE & ADMINISTRATION

    dosage and administration

  • WARNINGS

    warnings

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    purpose

  • INDICATIONS & USAGE

    indications and uses

  • ACTIVE INGREDIENT

    active ingredieants

  • INACTIVE INGREDIENT

    inactive ingredients

  • PRINCIPAL DISPLAY PANEL

    principal display panel

  • INGREDIENTS AND APPEARANCE
    YOWCH EXTRA STRENGTH FOR MINOR BURNS 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69804-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61) 60 mg  in 1000 mg
    MANGO SEED OIL (UNII: K8LOR30915) 35 mg  in 1000 mg
    PROPOLIS WAX (UNII: 6Y8XYV2NOF) 15 mg  in 1000 mg
    COCONUT OIL (UNII: Q9L0O73W7L) 25 mg  in 1000 mg
    WALNUT OIL (UNII: Y0P3555R51) 25 mg  in 1000 mg
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 70 mg  in 1000 mg
    EUCALYPTUS OIL (UNII: 2R04ONI662) 25 mg  in 1000 mg
    NUTMEG OIL (UNII: Z1CLM48948) 5 mg  in 1000 mg
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0) 25 mg  in 1000 mg
    ALMOND OIL (UNII: 66YXD4DKO9) 25 mg  in 1000 mg
    ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T) 25 mg  in 1000 mg
    COCOA BUTTER (UNII: 512OYT1CRR) 25 mg  in 1000 mg
    WITCH HAZEL (UNII: 101I4J0U34) 600 mg  in 1000 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69804-006-0256700 mg in 1 JAR; Type 0: Not a Combination Product11/30/2015
    2NDC:69804-006-03113400 mg in 1 JAR; Type 0: Not a Combination Product11/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/30/2015
    Labeler - Ridge Properties (029478762)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ridge Properties029478762manufacture(69804-006)