TheraCare 4% Lidocaine Cream

Manufacturer: Veridian Healthcare | Nantong Health & Beyond Hygienic Products Inc
Effective date: 2025-12-27
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: monthly-update
Hydrated at: 2026-06-03 17:52:54

Label at a glance#

ProductTheraCare 4% Lidocaine Cream

Active ingredientLIDOCAINE HYDROCHLORIDE

Label structure8 sections

Dosage and administration

adults and children over 12 years: ■ apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period ■ children 12 years or younger: ask a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

TheraCare 4% Lidocaine Cream. 2.7 oz

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 4%

Purpose

OTC - PURPOSE SECTION

Lidocaine HCl 4%............................................................................................................................Topical anesthetic

Use

INDICATIONS & USAGE SECTION

temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes

Do not use

OTC - DO NOT USE SECTION

■ on large areas of the body or on cut, irritated or swollen skin

■on puncture wounds

■ for more than one week without consulting a doctor

When using this product

OTC - WHEN USING SECTION

■ use only as directed. Read and follow all directions and warning on this carton.

■ do not allow contact with the eyes

■ do not bandage or apply local heat (such as heating pads) to the area of use

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ condition worsens

■ symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:

■ apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period

■ children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera leaf, carbopol 940, cetostearyl alcohol, dimethicone 350, edetate disodium, glycerin, glyceryl monostearate, isopropyl alcohol, phenoxyethanol, polysorbate 60, steareth 2, steareth 21, water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71101-933-01	2026-01-18	C162847	48780-1	3b156c62-2c24-fb37-e063-e6dba90a4e07	TheraCare 4% Lidocaine Cream
71101-933-01	2025-07-29	C162847	48780-1	3b156c62-2c24-fb37-e063-e6dba90a4e07	TheraCare 4% Lidocaine Cream

Products#

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

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

TheraCare 4% Lidocaine Cream
LIDOCAINE HYDROCHLORIDE
WATER
ISOPROPYL ALCOHOL
CETOSTEARYL ALCOHOL
CARBOMER 940
DIMETHICONE 350
STEARETH-2
POLYSORBATE 60
GLYCERYL MONOSTEARATE
ALOE VERA LEAF
GLYCERIN
PHENOXYETHANOL
STEARETH-21
EDETATE DISODIUM
LIDOCAINE
LIDOCAINE HYDROCHLORIDE ANHYDROUS

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71101-933	71101-933-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CARBOMER 940	4Q93RCW27E	IACT
DIMETHICONE 350	2Y53S6ATLU	IACT
STEARETH-2	V56DFE46J5	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
GLYCERIN	PDC6A3C0OX	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
STEARETH-21	53J3F32P58	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
LIDOCAINE HYDROCHLORIDE	V13007Z41A	ACTIR

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
46f7420d-f9fe-d14b-e063-6294a90a9034			ef18ba0e-e543-469b-e053-2995a90a46d8	2025-12-27	Warnings	Exact identifier spl id: 46f7420d-f9fe-d14b-e063-6294a90a9034 spl set id: ef18ba0e-e543-469b-e053-2995a90a46d8

Reported adverse events (FAERS/openFDA)#

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