FDA.reportPublic FDA data

Tylenol Precise Nighttime Pain Relieving Cream

Manufacturer
Kenvue Brands LLC
Effective date
2025-02-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:39

Label at a glance#

ProductTylenol Precise Nighttime Pain Relieving
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints

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 20˚ to 25 ˚C (68 ˚ to 77 ˚F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Camphor 4%............................................................................................. Topical analgesic

Menthol 1.25% ..........................................................................................Topical analgesic

OTC - PURPOSE SECTION

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes
  • do not apply to wounds or damaged, broken or irritated skin
  • 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

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. (1-800-222-1222)

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 20˚ to 25 ˚C (68 ˚ to 77 ˚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 or comments?

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

NEW

Nighttime

Pain Relieving Cream

Camphor 4% Menthol 1.25%

TYLENOL ®

PRECISE ®

Fast acting †

Dual

sensation †

Powerful

penetrating

pain relief

ROLLERBALL

APPLICATOR

Calming scent that

helps you relax

FOR EXTERNAL

USE ONLY

NET WT 4.0 OZ (113 g)

Tylenol_1Tylenol_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2604039camphor 4 % / menthol 1.25 % Topical CreamPSN1
2604039camphor 40 MG/ML / menthol 12.5 MG/ML Topical CreamSCD1
2604039camphor 4 % / menthol 1.25 % Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0905-4Tylenol Precise Nighttime Pain Relieving1 in 1 CARTONCREAM11
69968-0905-4Tylenol Precise Nighttime Pain Relieving113 g in 1 TUBECREAM1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0905TYLENOL PRECISE NIGHTTIME PAIN RELIEVING (CAMPHOR, MENTHOL) CREAM [KENVUE BRANDS LLC]1Current NDC, 2 package rows20250325_2ef4fe16-0820-6aad-e063-6294a90a8449.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-090569968-0905-4

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
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SORBITAN OLIVATEMDL271E3GRIACT
VANILLYL BUTYL ETHERS2ULN37C9RIACT
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 Nighttime Pain RelievingCAMPHOR, MENTHOLKenvue Brands LLC2ef4fe16-0820-6aad-e063-6294a90a84492025-02-25WarningsExact identifier
ndc (package): 69968-0905-4
ndc (product): 69968-0905
ndc11 (package): 69968090504
spl id: 2ef4fe0e-abe6-4601-e063-6394a90a99f9
spl set id: 2ef4fe16-0820-6aad-e063-6294a90a8449

Reported adverse events (FAERS/openFDA)#

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