FDA.reportPublic FDA data

Tylenol Precise Pain Relieving Cream

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:37:16

Label at a glance#

ProductTylenol Precise 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˚ to 30 ˚C (59 ˚ to 86 ˚F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% ………………………………………. Topical analgesic

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˚ to 30 ˚C (59 ˚ to 86 ˚F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carbomer copolymer, cetearyl olivate, cetyl alcohol, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, 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

​Pain Relieving

Cream

Lidocaine 4%

TYLENOL ®

PRECISE TM

Penetrating

pain relief

Targets pain

receptor nerves

Targets nerves

to block

pain signals

Numbs away

pain

ROLLER BALL

APPLICATOR

Maximum Strength Lidocaine

without a prescription

FRAGRANCE FREE*

For external

use only

NET WT 4.0 OZ (113 g)

TylenolTylenol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN3
1421893lidocaine 40 MG/ML Topical CreamSCD3
1421893lidocaine 4 % Topical CreamSY3

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
69968-0795-4Tylenol Precise Pain Relieving113 g in 1 TUBECREAM1133
69968-0795-4Tylenol Precise Pain Relieving1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0795TYLENOL PRECISE PAIN RELIEVING (LIDOCAINE) CREAM [KENVUE BRANDS LLC]3Current NDC, 2 package rows20241115_fc1e0451-8c84-729e-e053-6394a90aaba0.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-079569968-0795-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
SORBITAN OLIVATEMDL271E3GRIACT
LIDOCAINE98PI200987ACTIB
CETEARYL OLIVATE58B69Q84JOIACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT

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 RelievingLIDOCAINEKenvue Brands LLCfc1e0451-8c84-729e-e053-6394a90aaba02024-11-13WarningsExact identifier
ndc (package): 69968-0795-4
ndc (product): 69968-0795
ndc11 (package): 69968079504
spl id: 21ab1921-9d00-be70-e063-6394a90a5f20
spl set id: fc1e0451-8c84-729e-e053-6394a90aaba0

Reported adverse events (FAERS/openFDA)#

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