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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LIDOCAINE HCL 4%, BENZALKONIUM CHLORIDE 50% 0.2%
Available from:
EMS Contract Packaging
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
TOPICAL PAIN RELIEF ANTISEPTIC TOPICAL ANESTHETIC FOR USE DURING THE TATTOO PROCESS. PROMOTES FASTER HEALING, REDUCES REDNESS AND IRRITATION.
Authorization status:
OTC monograph not final
Authorization number:
59228-104-18

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

EMS Contract Packaging

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.

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ACTIVE INGREDIENTS

LIDOCAINE HCL 4%

BENZALKONIUM CHLORIDE 50% 0.2%

PURPOSE

TOPICAL PAIN RELIEF

ANTISEPTIC

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. 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

HOLY WATER MERCY IN A BOTTLE

lidocaine hcl, benzalkonium chloride solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 228 -10 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .1 g

in 10 0 0 mL

EMS Contract Packaging

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE -

UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

4 g in 10 0 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

EMU O IL (UNII: 3448 21WD6 1)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 228 -10 4-18

250 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/25/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 4/25/20 19

Labeler -

EMS Contract Packaging (048602791)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

EMS Co ntract Packaging

0 48 6 0 279 1

ma nufa c ture (59 228 -10 4)

Revised: 4/2019

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