FDA.reportPublic FDA data

Tylenol Precise Warming Pain Relieving Cream

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:36:56

Label at a glance#

ProductTylenol Precise Warming Pain Relieving
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

use only as directed adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Storage and handling

store at 15 0 to 30 0 C (59 0 to 86 0 F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

store at 15 0 to 30 0 C (59 0 to 86 0 F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, vanillyl butyl ether, water

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:

JOHNSON & JOHNSON CONSUMER INC.

Skillman, NJ 08558 USA

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Warming †

Pain Relieving Cream

Lidocaine 4%

TYLENOL ®

PRECISE TM

Fast acting †

Targeted

penetrating

pain relief

ROLLER BALL

APPLICATOR

Maximum Strength Lidocaine

without a prescription

LIGHTLY SCENTED

For external

use only

NET WT 4.0 OZ (113 g)

Tylenol_01Tylenol_01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN2
1421893lidocaine 40 MG/ML Topical CreamSCD2
1421893lidocaine 4 % Topical CreamSY2

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
69968-0794-4Tylenol Precise Warming Pain Relieving113 g in 1 TUBECREAM1132
69968-0794-4Tylenol Precise Warming Pain Relieving1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0794TYLENOL PRECISE WARMING PAIN RELIEVING (LIDOCAINE) CREAM [KENVUE BRANDS LLC]2Current NDC, 2 package rows20241115_0c60b607-ade9-68f2-e063-6394a90a4025.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-079469968-0794-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETEARYL OLIVATE58B69Q84JOIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
VANILLYL BUTYL ETHERS2ULN37C9RIACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
LIDOCAINE98PI200987ACTIB
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
SORBITAN OLIVATEMDL271E3GRIACT

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 Warming Pain RelievingLIDOCAINEKenvue Brands LLC0c60b607-ade9-68f2-e063-6394a90a40252024-11-13WarningsExact identifier
ndc (package): 69968-0794-4
ndc (product): 69968-0794
ndc11 (package): 69968079404
spl id: 21aaa192-9f47-141d-e063-6394a90ad1e7
spl set id: 0c60b607-ade9-68f2-e063-6394a90a4025

Reported adverse events (FAERS/openFDA)#

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