Label: PAIN RELIEF GEL-PATCH- lidocaine, menthol patch

  • NDC Code(s): 83016-171-01, 83016-171-07
  • Packager: R & Y Group, LLC
  • 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 June 15, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Lidocaine 4% w/w ...... Purpose: Topical Anesthetic

    Menthol 1% w/w ...... Purpose: Topical Analgesic

  • Purpose

    Topical Anesthetic (Lidocaine)

    Topical Analgesic (Menthol)

  • Use

    for temporary relief of pain

  • Warnings

    For External Use Only

  • Do not use

    • More than 1 patch at a time
    • If you are allergic to any ingredients of this product
    • On wounds or damaged skin
    • In large quantities, particularly over raw surfaces or blistered areas
  • When using this product

    • Use only as directed
    • Avoid contact with the eyes, mucous membranes or rashes
    • Do not bandage tightly
  • Stop use and consult a doctor if

    • Localized skin reactions occur, such as a rash, itching, redness, irritation, pain, swelling and blistering
    • Conditions worsen
    • Symptoms clear up and occur again within a few days
    • Symptoms persist for more than 7 days
  • If pregnant or breast-feeding,

    ask a physician before use.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and Children 12 years of age and over.

    • Clean and dry affected area
    • Remove film from patch and apply to the skin
    • Apply to affected area not more than 3 to 4 times daily
    • Remove patch from the skin after 8-hour application at most

    Children under 12 years of age: Consult a physician

  • Other Information

    • Store at 68° - 77° F (20° - 25° C)
    • Store in a cool dry place away from direct sunlight
  • Inactive Ingredients

    Dihydroxyaluminium Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral Oil, Polyacrylic Acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide, Water

  • Package label. Principal display panel

    0107

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF GEL-PATCH 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83016-171
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.12 g  in 12 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.48 g  in 12 g
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83016-171-077 in 1 POUCH06/15/2023
    1NDC:83016-171-0112 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/15/2023
    Labeler - R & Y Group, LLC (968585765)
    Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Chuangshi Medical Technology (Group) Co., Ltd.546872672manufacture(83016-171)