Label: RUGBY LIDOCAINE- lidocaine cream

  • NDC Code(s): 0536-1139-20, 0536-1139-28
  • Packager: Rugby Laboratories
  • 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 January 14, 2021

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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 notallow 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 ot affected area every 6 t o8 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

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Phenoxyethanol, SD Alcohol 40, Steareth-21, Water (purified)

  • Questions?(800)645-2158

  • Principal Panel-Tube

    RUGBY® NDC 0536-1139-20

    Maxium Strength

    4% Lidocaine

    Pain Relieving Cream

    NET WT. 15g (0.52 oz)

    Principal Panel-Tube

  • Principal Panel - Carton

    RUGBY® NDC 0536-1139-20

    Maxium Strength

    4% Lidocaine

    Pain Relieving Cream

    NET WT. 15g (0.52 oz)

    Principal Panel - Carton

  • INGREDIENTS AND APPEARANCE
    RUGBY LIDOCAINE 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1139
    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
    WATER (UNII: 059QF0KO0R)  
    SILICON (UNII: Z4152N8IUI)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARETH-21 (UNII: 53J3F32P58)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETEARETH-2 PHOSPHATE (UNII: 8NSU66JGZR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1139-201 in 1 CARTON09/21/2018
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0536-1139-281 in 1 CARTON11/27/2018
    230 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 finalpart34809/21/2018
    Labeler - Rugby Laboratories (079246066)
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