Label: EXTRA STRENGTH POSTPARTUM RELIEF- lidocaine hcl spray

  • 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 March 31, 2017

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  • DOSAGE & ADMINISTRATION

    dosage and administration

  • WARNINGS

    warnings

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    otc purpose

  • INDICATIONS & USAGE

    inidications and usage

  • ACTIVE INGREDIENT

    active ingredients

  • INACTIVE INGREDIENT

    inactive ingredients

  • PRINCIPAL DISPLAY PANEL

    package label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH POSTPARTUM RELIEF 
    lidocaine hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69804-043
    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
    WITCH HAZEL (UNII: 101I4J0U34) 510 mg  in 1000 mg
    PIPER METHYSTICUM WHOLE (UNII: 3P306S300W) 200 mg  in 1000 mg
    ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43) 75 mg  in 1000 mg
    COPAIBA OIL (UNII: 64VX45Y68N) 100 mg  in 1000 mg
    NUTMEG OIL (UNII: Z1CLM48948) 75 mg  in 1000 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69804-043-0814200 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/03/2017
    2NDC:69804-043-0728500 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/03/2017
    3NDC:69804-043-0156700 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/03/2017
    4NDC:69804-043-04113400 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/03/2017
    Labeler - ridge properteis (029478762)
    Establishment
    NameAddressID/FEIBusiness Operations
    ridge properties029478762manufacture(69804-043)