Label: ASPERCREME WITH LIDOCAINE FOOT PAIN CREME- lidocaine hydrochloride cream

  • 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 19, 2021

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  • SPL UNCLASSIFIED SECTION

    ASPERCREME LIDOCAINE FOOT CREME

    Drug Facts

  • Active ingredient

    Lidocaine HCl 4%

  • Purpose

    Topical anesthetic

  • Use

    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 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 mucus membranes
    • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch 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.

    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
    • massage into painful area until thoroughly absorbed into skin

    children 12 years or younger: ask a doctor

  • Inactive ingredients

    water, SD alcohol 40 (10%), cetearyl alcohol, ceteth-20 phosphate, dimethicone, caprylyl methicone, dicetyl phosphate, glyceryl stearate, aloe barbadensis leaf juice, panthenol, tocopheryl acetate, magnesium ascorbyl phosphate, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, acrylates/C10-30 alkyl acrylate crosspolymer, ethylhexylglycerin, methylparaben, disodium EDTA, citric acid

    Child-resistant packaging. Close cap tightly after use.

  • PRINCIPAL DISPLAY PANEL

    MAX STRENGTH
    Aspercreme
    WITH 4% LIDOCAINE
    PAIN RELIEF CREAM
    NET WT 4 OZ (113 g) 

    MAX STRENGTH Aspercreme WITH 4% LIDOCAINE PAIN RELIEF CREAM NET WT 4 OZ (113 g)

  • INGREDIENTS AND APPEARANCE
    ASPERCREME WITH LIDOCAINE FOOT PAIN CREME 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0586
    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
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0586-21 in 1 CARTON03/01/2018
    1113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2018
    Labeler - Chattem, Inc. (003336013)
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