Label: HOLY WATER MERCY IN A BOTTLE- lidocaine hcl, benzalkonium chloride solution

  • NDC Code(s): 59228-104-18
  • Packager: EMS Contract Packaging
  • 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 April 22, 2022

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  • ACTIVE INGREDIENTS

    LIDOCAINE HCL   4%

    BENZALKONIUM CHLORIDE 50%  0.2%

  • PURPOSE

    TOPICAL PAIN RELIEF

    ANTISEPTIC

  • INDICATIONS & USAGE

    TOPICAL ANESTHETIC FOR USE DURING THE TATTOO PROCESS. PROMOTES FASTER HEALING, REDUCES REDNESS AND IRRITATION.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    ASK A DOCTOR BEFORE USE IF YOU HAVE A CONDITION THAT COVERS A LARGE AREA OF THE BODY. WHEN USING THIS PRODUCT: AVOID CONTACT WITH EYES. IF CONTACT OCCURS RINSE EYES THOROUGHLY WITH WATER; DISCONTINUE USE IF EXCESSIVE INFLAMMATION OCCURS. IF CONDITION WORSENS OR DOES NOT IMPROVE WITH REGULAR USE AS DIRECTED, CONSULT A PHYSICIAN.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED GET MEDICAL ATTENTION OR CONTACT THE POISON CONTROL CENTER IMMEDIATELY.

  • CAUTION

    DO NOT FREEZE. STORE IN A COOL PLACE BELOW 77 DEGREES F (25 DEGREES C)

  • DIRECTIONS:

    SHAKE WELL PRIOR TO USE. CLEAN AREA. APPLY HOLY WATER GENEROUSLY AND AS NEEDED THROUGHOUT TATTOO PROCESS. EFFECTIVE ON OPEN SKIN ONLY.

  • INACTIVE INGREDIENTS:

    EMU OIL, PURIFIED WATER, PROPYLENE GLYCOL, ALOW VERA, FRAGRANCE

  • PRINCIPAL DISPLAY PANEL

    LBL_Holy Water_Pain Spray_250mL

  • INGREDIENTS AND APPEARANCE
    HOLY WATER MERCY IN A BOTTLE 
    lidocaine hcl, benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59228-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 1000 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EMU OIL (UNII: 344821WD61)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59228-104-18250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/25/2019
    Labeler - EMS Contract Packaging (048602791)
    Establishment
    NameAddressID/FEIBusiness Operations
    EMS Contract Packaging048602791manufacture(59228-104)