Label: TYLENOL PRECISE COOLING PAIN RELIEVING- lidocaine, menthol cream

  • NDC Code(s): 69968-0793-1, 69968-0793-4
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

    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)

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    JOHNSON & JOHNSON

    CONSUMER INC.

    Skillman, NJ 08558 USA

  • 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

  • INGREDIENTS AND APPEARANCE
    TYLENOL PRECISE COOLING PAIN RELIEVING 
    lidocaine, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0793
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0793-11 in 1 CARTON07/03/2023
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69968-0793-41 in 1 CARTON07/03/2023
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/03/2023
    Labeler - Kenvue Brands LLC (118772437)
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