Label: SATOHAP LIDOCAINE 4% MENTHOL 1% PAIN RELIEVING CREAM- lidocaine, menthol cream

  • NDC Code(s): 49873-619-01
  • Packager: Sato Pharmaceutical Co., Ltd.
  • 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 November 14, 2018

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  • ACTIVE INGREDIENT

    Active ingredients

    Lidocaine 4%

    Menthol 1%

  • PURPOSE

    Purpose

    Lidocaine  Topical analgesic

    Menthol   Topical analgesic

  • INDICATIONS & USAGE

    Uses

    For temporary relief of pain

  • WARNINGS

    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 the eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • a rash or irritation develops

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times dailly
    • children under 12 years of age: do not use, ask a doctor
  • OTHER SAFETY INFORMATION

    Other information

    • protect product from excessive moisture
    • avoid storing in direct sunlight
    • store with lid tightly closed
  • INACTIVE INGREDIENT

    Inactive ingredients benzyl alcohol, butylene glycol, carbomer homopolymer (type C), isopropyl myristate, polyoxyl 40 hydrogenated castor oil, sodium hydroxide, water

  • PRINCIPAL DISPLAY PANEL

    PDP

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    SATOHAP LIDOCAINE 4% MENTHOL 1% PAIN RELIEVING CREAM 
    lidocaine, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-619
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-619-011 in 1 CARTON11/14/2018
    1100 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 finalpart34811/14/2018
    Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical Co., Ltd.715699133pack(49873-619) , label(49873-619) , manufacture(49873-619)