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Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558 USA
Tylenol Precise Nighttime Pain Relieving Cream
FDA Label NDC 69968-0905
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 Nighttime Pain Relieving (NDC 69968-0905). 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, otc - active ingredient, otc - purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients Purpose
Camphor 4%............................................................................................. Topical analgesic
Menthol 1.25% ..........................................................................................Topical analgesic
Otc - Purpose
Uses
For the temporary relief of minor aches and pains of muscles and joints
Warnings
For external use only.
Otc - When Using
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
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. (1-800-222-1222)
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 20˚ to 25 ˚C (68 ˚ to 77 ˚F)
Inactive Ingredients
carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, vanillyl butyl ether, water
Questions Or Comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Principal Display Panel - 113 G Tube Carton
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_1 (Tylenol 1)
* Please review the disclaimer below.
