FDA.reportPublic FDA data

Tylenol Precise Pain Relieving Patch Lidocaine 4%

Manufacturer
Kenvue Brands LLC
Effective date
2025-09-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:15:14

Label at a glance#

ProductTylenol Precise Pain Relieving Lidocaine 4%
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

adults and children 12 years of age and older: children 12 to under 18 years of age, use with adult supervision apply contents of one pouch to affected area not more than 3 to 4 times daily remove a patch after at most 12 hours single-use patch. Do not reapply fold used patches so that the adhesive side sticks to itself and safely discard where children cannot get to them children under 12 years of age: do not use

Storage and handling

Store at 20°C to 25°C (68°F - 77°F) ■ Open pouches are not child resistant.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Lidocaine 4%

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • more than one patch at a time
  • on wounds or damaged skin
  • on raw surfaces or blistered areas
  • with a heating pad

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If put in mouth or swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older:

children 12 to under 18 years of age, use with adult supervision

  • apply contents of one pouch to affected area not more than 3 to 4 times daily
  • remove a patch after at most 12 hours
  • single-use patch. Do not reapply
  • fold used patches so that the adhesive side sticks to itself and safely discard where children cannot get to them

children under 12 years of age: do not use

Other Information

STORAGE AND HANDLING SECTION

Store at 20°C to 25°C (68°F - 77°F) ■ Open pouches are not child resistant.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

diacetone acrylamide - acrylamidomethylpropane sulfonic acid copolymer, diethylene glycol monoethyl ether, ethylparaben, glycerin, isopropyl laurate, methylparaben, polysorbate 80, povidone, propylene glycol, water, sodium hydroxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - Tylenol Patch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

TYLENOL ®

PRECISE TM

Pain Relieving Patch

Lidocaine 4% Topical Analgesic

Targeted penetrating pain relief

12

Stays on for

up to 12 hours

Designed with

specialized

adhesion

technology

Maximum

Strength

Lidocaine without

a prescription

4 INDIVIDUALLY SEALED PATCHES

3.3 in X 4.4 in (8.3 cm X 11.1 cm)

See back of carton for actual size

UNSCENTED

FOR EXTERNAL USE ONLY

Tylenol_1Tylenol_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN2
1737778lidocaine 0.04 MG/MG Medicated PatchSCD2
1737778lidocaine 4 % Medicated PatchSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0927-2Tylenol Precise Pain Relieving Lidocaine 4%2 in 1 CARTONPATCH22
69968-0927-2Tylenol Precise Pain Relieving Lidocaine 4%1 in 1 POUCHPATCH12
69968-0927-3Tylenol Precise Pain Relieving Lidocaine 4%2 in 1 POUCHPATCH22
69968-0927-3Tylenol Precise Pain Relieving Lidocaine 4%3 in 1 CARTONPATCH32
69968-0927-4Tylenol Precise Pain Relieving Lidocaine 4%1 in 1 POUCHPATCH12
69968-0927-4Tylenol Precise Pain Relieving Lidocaine 4%4 in 1 CARTONPATCH42

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-092769968-0927-3, 69968-0927-2, 69968-0927-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL LAURATEU0JQ94LABMIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
Tylenol Precise Pain Relieving Lidocaine 4%LIDOCAINEKenvue Brands LLC36a95afd-97e5-2271-e063-6394a90aea182025-09-30WarningsExact identifier
ndc (package): 69968-0927-4
ndc (package): 69968-0927-3
ndc (package): 69968-0927-2
ndc (product): 69968-0927
ndc11 (package): 69968092702
ndc11 (package): 69968092703
ndc11 (package): 69968092704
spl id: 4003f398-d2da-e2cc-e063-6394a90a18f4
spl set id: 36a95afd-97e5-2271-e063-6394a90aea18

Reported adverse events (FAERS/openFDA)#

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