FDA.reportPublic FDA data

TheraCare Roll-on Lidocaine Pain Relief Liquid

Manufacturer
Veridian Healthcare | Nantong Health & Beyond Hygienic Products Inc
Effective date
2025-09-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:14:21

Label at a glance#

ProductTheraCare Roll-on Lidocaine Pain Relief Liquid
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

temporarily relieves minor pain

Dosage and administration

adults and children over 12 years: apply a thin layer to 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

TheraCare Roll-on Lidocaine Pain Relief Liquid 

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with the eyes and mucus membranes
  • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
  • do not use at the same time as other topical analgesics

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable■ Keep away from fire or flame

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 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

Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer (60000 MPA.S), aloe barbadensis leaf juice, aminomethylpropanol,
ceteth-10 phosphate, cetostearyl alcohol, cyclomethicone 5, dicetyl phosphate, dimethicone 350, dimethicone/vinyl dimethicone
crosspolymer (soft particle), disodium EDTA, ethylhexylglycerin, glyceryl 1 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate
copolymer (100000 MPA.S at 1.5%), isohexadecane, phenoxyethanol, SD alcohol, steareth-21, water

Questions or comments

OTC - QUESTIONS SECTION

Call 1-866-326-1313

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-087-01TheraCare Roll-on Lidocaine Pain Relief Liquid73 mL in 1 BOTTLE, WITH APPLICATORLIQUID731
71101-087-01TheraCare Roll-on Lidocaine Pain Relief Liquid1 in 1 CARTONLIQUID11

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71101-08771101-087-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL 1-STEARATE258491E1RZIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ISOHEXADECANE918X1OUF1EIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
ALCOHOL3K9958V90MIACT
CYCLOMETHICONE 50THT5PCI0RIACT
WATER059QF0KO0RIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
DIMETHICONE 3502Y53S6ATLUIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARETH-2153J3F32P58IACT
LIDOCAINE98PI200987ACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare Roll-on Lidocaine Pain Relief LiquidLIDOCAINE HCIVeridian Healthcaree942d447-754d-4683-9c99-57c7e83d7ea82025-09-18WarningsExact identifier
ndc (package): 71101-087-01
ndc (product): 71101-087
ndc11 (package): 71101008701
spl id: 3f1bae48-7bd7-ffdb-e063-6394a90aa465
spl set id: e942d447-754d-4683-9c99-57c7e83d7ea8

Reported adverse events (FAERS/openFDA)#

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