SITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]

SITEROL (LIDOCAINE HCL, MENTHOL) PATCH [BINGER CONSULTING CORPORATION]
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NDC 69440-007-15
Set ID 1ef21407-5fd2-4349-8d4f-af3b13dab476
Category HUMAN OTC DRUG LABEL
Packager Binger Consulting Corporation
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • ​​Drug Facts

  • Active ingredient

    Lidocaine HCL 3.99%

    Menthol 1.00%

  • Purpose

    Topical Analgesic

    External Analgesic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Consult physician for children under 12.

  • Uses

    • temporary relief of pain associated with minor cuts, scrapes, and minor skin irritations

  • Warnings

    For external use only

    Do not use

    • if pregnant or breastfeeding, consult physician prior to use

    • in large quantities, particularly over raw surfaces or blistered areas

    When using this product

    • use only as directed • do not bandage tightly • avoid contact with eyes

    • do not apply to open wounds or damaged skin

    Stop use and ask a doctor if

    • symptoms persist for more than seven days, discontinue use and consult physician

    • swallowed, consult physician

  • Directions

    How to apply • clean and dry affected area • remove patch from backing and apply to affected area • use only one patch at a time, and maximum of four patches/day • leave patch on affected area for upto 8-hours • do not use patches for longer than five consecutive days

  • INACTIVE INGREDIENT

    Other ingredients aloe barbadensis leaf (aloe vera juice) gel, aqua (deionized water), arnica montana extract, boswellia serrata extract, camellia sinensis leaf (green tea) extract, carbomer, ethylhexylglycerin, glycerin, isopropyl myristate, PEG-8, phenoxyethanol, polysorbate-80, sodium lauryl sulfate, triethanolamine, FD C blue 1, FD C yellow 5

  • QUESTIONS

    Questions or comments? ​call weekdays from 9 AM to 5 PM PST 888-501-5651

  • STORAGE AND HANDLING

    Other information store below 25°C (77° F), avoid direct sunlight

  • Packaging

    Siterol

  • INGREDIENTS AND APPEARANCE
    SITEROL 
    lidocaine hcl, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69440-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE3.99 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PEG-8 GLYCERYL ISOSTEARATE (UNII: 74QQ5X3KL1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69440-007-1515 in 1 BOX01/01/2015
    1100 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2015
    Labeler - Binger Consulting Corporation (079635976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Active Intelligence, LLC080416593manufacture(69440-007)

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