Label: ASPERCREME LIDOCAINE FOOT (DIABETIC)- 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 May 6, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    ASPERCREME with LIDOCAINE FOOT PAIN CREAM

    (For Diabetic Skin)

    Drug Facts

  • Active ingredient

  • Purpose

    Lidocaine HCl 4%............................................................................................................................Topical anesthetic

  • Use

    temporarily relieves minor pain

  • Warnings

    For external use only 

    Do not use

    ■ if you have serious foot problems, such as ulcers or infections 

    ■ if you have numbness or reduced ability to feel pain

    ■ 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 warning on this carton.

    ■ do not allow contact with the eyes and the mucous 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, alcohol denat. (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

                                                                                       333-105

    Child-resistant packaging. Close cap tightly after use.

  • PRINCIPAL DISPLAY PANEL

    Max Strength
    Aspercreme
    Lidocaine

    2 in 1

    Pain Relief + Moisturization

    foot cream

    PRINCIPAL DISPLAY PANEL
Max Strength
Aspercreme
Lidocaine
2 in 1
Pain Relief + Moisturization
foot cream

  • INGREDIENTS AND APPEARANCE
    ASPERCREME LIDOCAINE FOOT (DIABETIC) 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0597
    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)  
    C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0597-01 in 1 CARTON06/01/2018
    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 finalpart34806/01/2018
    Labeler - Chattem, Inc. (003336013)