Label: ASPERCREME WITH LIDOCAINE PAIN RELIEVING CREME- lidocaine hydrochloride lotion

  • NDC Code(s): 41167-0582-1, 41167-0582-2, 41167-0582-4, 41167-0582-5, view more
    41167-0582-8
  • Packager: Chattem, Inc.
  • 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 August 1, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine HCI 4%

  • Purpose

    Topical anesthetic

  • Uses

    temporarily relieves minor pain 

  • Warnings

    For external use only

    Do not use

    • on puncture wounds
    • on large areas of the body or on cut, irritated or swollen skin
    • for more than one week without consulting 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 and mucous membranes
    • do not bandage or apply local heat (such as heating pads) to the area of use
    • do not use at the same time as other topical analgesics

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms 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 out of reach of children and pets.

    If swallowed, get medical help or contact a 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 12 years and younger: ask a doctor

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), 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, methylparaben, steareth-21, water

  • PRINCIPAL DISPLAY PANEL

    ODOR FREE
    Aspercreme
    WITH 4% LIDOCAINE
    MAXIMUM STRENGTH
    Pain Relieving CREME
    Net wt 2.7 oz (76.5 g)

    PRINCIPAL DISPLAY PANEL ODOR FREE Aspercreme WITH 4% LIDOCAINE MAXIMUM STRENGTH Pain Relieving CREME Net wt 2.7 oz (76.5 g)  

  • INGREDIENTS AND APPEARANCE
    ASPERCREME WITH LIDOCAINE PAIN RELIEVING CREME 
    lidocaine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0582
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    STEARETH-21 (UNII: 53J3F32P58)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0582-51 in 1 CARTON12/01/2014
    176.5 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41167-0582-21 in 1 CARTON12/01/2014
    249.6 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:41167-0582-81 in 1 CARTON12/01/2014
    3133 g in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:41167-0582-42 in 1 CARTON12/01/201401/31/2021
    4113 g in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:41167-0582-11 in 1 CARTON11/01/2020
    5121 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2014
    Labeler - Chattem, Inc. (003336013)
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