FDA.reportPublic FDA data

HOLY WATER MERCY IN A BOTTLE

Manufacturer
EMS Contract Packaging
Effective date
2022-04-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:02:41

Label at a glance#

ProductHOLY WATER MERCY IN A BOTTLE
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

LIDOCAINE HCL   4%

BENZALKONIUM CHLORIDE 50%  0.2%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL PAIN RELIEF

ANTISEPTIC

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

CAUTION

STORAGE AND HANDLING SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LBL_Holy Water_Pain Spray_250mLLBL_Holy Water_Pain Spray_250mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59228-104-182025-01-30C16284748780-12cef2736-af55-d83d-e063-dadaa90ab31fEMS (as CMO) - Holy Water (59228-104)

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59228-104HOLY WATER MERCY IN A BOTTLE (LIDOCAINE HCL, BENZALKONIUM CHLORIDE) SOLUTION [EMS CONTRACT PACKAGING]4Legacy NDC20220423_1933d0fa-c1b1-4390-bc79-b83c85871c49.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59228-10459228-104-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
EMU OIL344821WD61IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dd46426d-7112-0d40-e053-2995a90a7e1a1933d0fa-c1b1-4390-bc79-b83c85871c492022-04-22WarningsExact identifier
spl id: dd46426d-7112-0d40-e053-2995a90a7e1a
spl set id: 1933d0fa-c1b1-4390-bc79-b83c85871c49

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.