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Drug Facts
Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558 USA
Tylenol Precise Cooling Pain Relieving Cream
FDA Label NDC 69968-0793
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Tylenol Precise Cooling Pain Relieving (NDC 69968-0793). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine 4%............................................................................................... Topical analgesic
Menthol 1%.................................................................................................. Topical analgesic
Purpose
Topical analgesic
Uses
For the temporary relief of pain
Warnings
For external use only.
Do Not Use
▪ in large quantities, particularly over raw surfaces or blistered areas
When Using This Product
▪ avoid contact with eyes
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- 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
store at 15 ◦ to 30 ◦ C (59 ◦ to 86 ◦ F)
Inactive Ingredients
carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, water
Questions?
Call 1-877-895-3665 (toll-free) or 215- 273-8755 (collect)
Principal Display Panel - 113 G
Cooling+
Pain Relieving Cream
Lidocaine 4% Menthol 1%
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 (Tylenol 01)
* Please review the disclaimer below.
