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

HOLY WATER MERCY IN A BOTTLE by

Drug Labeling and Warnings

HOLY WATER MERCY IN A BOTTLE by is a Otc medication manufactured, distributed, or labeled by EMS Contract Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59228-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 1000 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EMU OIL (UNII: 344821WD61)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59228-104-18	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/25/2019

Labeler - EMS Contract Packaging (048602791)

Establishment
Name	Address	ID/FEI	Business Operations
EMS Contract Packaging		048602791	manufacture(59228-104)