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

  • NDC Code(s): 69968-0793-1, 69968-0793-4
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 24, 2023

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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 not finalpart34807/03/2023
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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