Label at a glance#

ProductLidocaine

Active ingredientLIDOCAINE

Label structure8 sections

Indications and uses

For temporary relief of pain and itching due to minor skin irritation.

Dosage and administration

For adulst and children two-years or older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4.0%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching due to minor skin irritation.

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if

OTC - STOP USE SECTION

Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For adulst and children two-years or older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

FDA Registered: NDC No. 54723-000-00 info@sambriapharma.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1421893	Lidocaine (Topical)	lidocaine 40 MG/ML Topical Cream	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1421893	lidocaine 4 % Topical Cream	PSN	6
1421893	lidocaine 40 MG/ML Topical Cream	SCD	6
1421893	lidocaine 4 % Topical Cream	SY	6

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54723-200-00	2025-01-30	C162847	48780-1	2cef2736-6bfe-d83d-e063-dadaa90ab31f	Lidocaine Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54723-200-00	Lidocaine	2 mL in 1 PACKET	CREAM	2		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54723-200	LIDOCAINE CREAM [SAMBRIA PHARMACEUTICALS INC.]	6	Legacy NDC, 1 package rows	20231101_dbed2cc9-4928-436b-b303-e421a0e1e1f6.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Lidocaine
WATER
ARNICA MONTANA FLOWER
C13-14 ISOPARAFFIN
EMU OIL
DIETHYLENE GLYCOL MONOETHYL ETHER
ETHYLHEXYLGLYCERIN
GLUCOSAMINE SULFATE
ISOPROPYL PALMITATE
LAURETH-7
TEA TREE OIL
DIMETHYL SULFONE
PHENOXYETHANOL
PROPYLENE GLYCOL
STEARIC ACID
TROLAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54723-200	54723-200-00

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
WATER	059QF0KO0R	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
C13-14 ISOPARAFFIN	E4F12ROE70	IACT
EMU OIL	344821WD61	IACT
DIETHYLENE GLYCOL MONOETHYL ETHER	A1A1I8X02B	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
GLUCOSAMINE SULFATE	1FW7WLR731	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
LAURETH-7	Z95S6G8201	IACT
TEA TREE OIL	VIF565UC2G	IACT
DIMETHYL SULFONE	9H4PO4Z4FT	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TROLAMINE	9O3K93S3TK	IACT
LIDOCAINE	98PI200987	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0904f675-97c8-f3a2-e063-6394a90aa127			dbed2cc9-4928-436b-b303-e421a0e1e1f6	2023-10-31	Warnings	Exact identifier spl id: 0904f675-97c8-f3a2-e063-6394a90aa127 spl set id: dbed2cc9-4928-436b-b303-e421a0e1e1f6

Reported adverse events (FAERS/openFDA)#

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

Lidocaine Cream