Zcaine Fast Acting Anesthetic Gel

Manufacturer: PHI, Inc | Filltech USA, LLC
Effective date: 2023-11-09
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:59:45

Label at a glance#

ProductZcaine Fast Acting Anesthetic

Active ingredientLIDOCAINE

Label structure7 sections

Indications and uses

For the temporary relief of discomfort and pain associated with minor burns and skin irritations minor cuts and scrapes itching

Dosage and administration

Adults and children 12 years of age or older: Apply to affected area not more than 3 to 4 times daily.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of discomfort and pain associated with

minor burns and skin irritations
minor cuts and scrapes
itching

Warnings:

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

In large quantities, particularly over raw surfaces or blistered areas Do not use

Stop use and ask a doctor if

skin becomes irritated
condition worsens or symptoms last more than 7 days
symptoms clear up and reoccur within a few days

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age or older: Apply to affected area not more than 3 to 4 times daily.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

Zcaine Fast Acting Anesthetic Gel 2oz/60g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZcaineTubeZcaineFrontPanel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1291672	lidocaine 4 % Topical Gel	PSN	4
1292877	Zcaine 4 % Topical Gel	PSN	4
1292877	lidocaine 0.04 MG/MG Topical Gel [Zcaine]	SBD	4
1291672	lidocaine 0.04 MG/MG Topical Gel	SCD	4
1291672	lidocaine 4 % Topical Gel	SY	4
1292877	Zcaine 0.04 MG/MG Topical Gel	SY	4
1292877	Zcaine 4 % Topical Gel	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
27789-911-02	Zcaine Fast Acting Anesthetic	60 g in 1 BOTTLE	GEL	60		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27789-911	ZCAINE FAST ACTING ANESTHETIC (LIDOCAINE) GEL [PHI, INC]	4	Current NDC, Legacy NDC, 1 package rows	20231110_d072243f-6ba6-4ab6-8ebf-a2381fa9c2df.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	1
COMFREY LEAF	INACTIVE INGREDIENT	DG4F8T839X	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Zcaine Fast Acting Anesthetic
LIDOCAINE
ALOE VERA LEAF
CALENDULA OFFICINALIS FLOWER
GREEN TEA LEAF
CHAMOMILE
DIAZOLIDINYL UREA
EDETATE DISODIUM
GLYCERIN
MENTHOL
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
ALCOHOL
COMFREY LEAF
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
27789-911	27789-911-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALOE VERA LEAF	ZY81Z83H0X	IACT
CALENDULA OFFICINALIS FLOWER	P0M7O4Y7YD	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
CHAMOMILE	FGL3685T2X	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERIN	PDC6A3C0OX	IACT
MENTHOL	L7T10EIP3A	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
COMFREY LEAF	DG4F8T839X	IACT
TROLAMINE	9O3K93S3TK	IACT
LIDOCAINE	98PI200987	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 6 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii+route 6 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zcaine Fast Acting Anesthetic	LIDOCAINE	PHI, Inc	d072243f-6ba6-4ab6-8ebf-a2381fa9c2df	2023-11-09	Warnings	Exact identifier ndc (package): 27789-911-02 ndc (product): 27789-911 ndc11 (package): 27789091102 spl id: 09c29a75-1487-1335-e063-6394a90a7f27 spl set id: d072243f-6ba6-4ab6-8ebf-a2381fa9c2df

Reported adverse events (FAERS/openFDA)#

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