Label: DR SAYMANS WONDER RUB- lidocaine gel

  • NDC Code(s): 11527-384-22
  • Packager: Sheffield Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine HCL 4%

  • Purpose

    Topical anesthetic

  • Uses

    • Temporarily relieves minor pain
  • Warnings

    For external use only

    Do not use

    • on large areas of the body or on cut,irritated or swollen skin
    • on puncture wounds
    • for more than one week without consultanting a doctor

    When using this product

    • use only as directed. Read and follow all directions and warnings on this carton.
    • do not allow contact with the eyes
    • do not bandage or apply local heat (such as heating pads) to the area of use.

    Stop use and ask a doctor if

    • condition worsens
    • symptons persist for more than 7 days or clear up and occur again within a few days.

    If pregnant or breast feeding, ask a health professional before use. 

    Keep this and all drugs out of the reach of children and pets.

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

  • Directions

    • Adults and children over 12 years: 
    • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
    • Children under 12 years  or younger: ask a doctor

  • Other information

    • Store at controlled room temperature 20°-25°C (68°-77°F)
  • Inactive Ingredients: Alcohol, Arnica Montana Extract, Cannabis Sativa Seed Oil, Cyclohexasiloxane, Cyclopentasiloxane, Glycerin, PEG/PPG-18/18 Dimethicone, Menthane Carboxamidoethyl Acetate, Phenoxyethanol, Potassium Hydroxide, Sodium Chloride, Water (purified)

  • Questions?(800)645-2158

  • Principal Panel-Tube

    Dr Sayman Wonder Rub  

    Maximum Strength

    4% Lidocaine

    Pain Relieving 

    NET WT. 4.0 oz (113g)

    Wonder Rub tube.jpg

  • Principal Panel - Carton

    Dr.Sayman's Wonder Rub 

    Maximum Strength

    4% Lidocaine

    Pain Relieving 

    NET WT. 4.0 oz (113g)

    Principal Panel - Carton

  • INGREDIENTS AND APPEARANCE
    DR SAYMANS WONDER RUB 
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-384
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    N-((ETHOXYCARBONYL)METHYL)-P-MENTHANE-3-CARBOXAMIDE (UNII: Q6CA504696)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11527-384-221 in 1 CARTON02/21/2019
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/21/2019
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(11527-384)
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