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NDC 59228-0104-18 HOLY WATER MERCY IN A BOTTLE .1; 4 g/1000mL; g/1000mL Details
HOLY WATER MERCY IN A BOTTLE .1; 4 g/1000mL; g/1000mL
HOLY WATER MERCY IN A BOTTLE is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by EMS Contract Packaging. The primary component is BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE.
Product Information
NDC | 59228-0104 |
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Product ID | 59228-104_dd46426d-7112-0d40-e053-2995a90a7e1a |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | HOLY WATER MERCY IN A BOTTLE |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | LIDOCAINE HCL, BENZALKONIUM CHLORIDE |
Product Type | HUMAN OTC DRUG |
Dosage Form | SOLUTION |
Route | TOPICAL |
Active Ingredient Strength | .1; 4 |
Active Ingredient Units | g/1000mL; g/1000mL |
Substance Name | BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE |
Labeler Name | EMS Contract Packaging |
Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part348 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 59228-0104-18 (59228010418)
NDC Package Code | 59228-104-18 |
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Billing NDC | 59228010418 |
Package | 250 mL in 1 BOTTLE (59228-104-18) |
Marketing Start Date | 2019-04-25 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1933d0fa-c1b1-4390-bc79-b83c85871c49 Details
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
DIRECTIONS:
INGREDIENTS AND APPEARANCE
HOLY WATER MERCY IN A BOTTLE
lidocaine hcl, benzalkonium chloride solution |
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Labeler - EMS Contract Packaging (048602791) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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EMS Contract Packaging | 048602791 | manufacture(59228-104) |
Revised: 4/2022
Document Id: dd46426d-7112-0d40-e053-2995a90a7e1a
Set id: 1933d0fa-c1b1-4390-bc79-b83c85871c49
Version: 4
Effective Time: 20220422