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| Product NDC Code | 69968-0793 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tylenol precise cooling pain relieving |
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| Type | Brand | ||||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | M017 | ||||||
| Labeler Name | Kenvue Brands LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Lidocaine 4%............................................................................................... Topical analgesic Menthol 1%.................................................................................................. Topical analgesic
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the temporary relief of pain
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Tylenol Precise Cooling Pain Relieving Lidocaine, Menthol MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM CETEARYL OLIVATE CETYL ALCOHOL GLYCERIN ISOPROPYL PALMITATE PHENOXYETHANOL WATER LIDOCAINE LIDOCAINE SODIUM POLYACRYLATE (2500000 MW) SORBITAN OLIVATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558 USA
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-877-895-3665 (toll-free) or 215- 273-8755 (collect)
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.Do not use ▪ in large quantities, particularly over raw surfaces or blistered areas
When using this product ▪ avoid contact with eyes
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at 15 ◦ to 30 ◦ C (59 ◦ to 86 ◦ F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API