Label: ASPERCREME LIDOCAINE NO-MESS BERGAMOT ORANGE- lidocaine hydrochloride liquid

  • 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 25, 2021

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  • SPL UNCLASSIFIED SECTION

    ASPERCREME LIDOCAINE WITH BERGAMOT NO-MESS

    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 mucous membranes

    ■ do not bandage 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

    Flammable  ■ Keep away from fire or flame

    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

    children 12 years or 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, citrus aurantium bergamia (bergamot) fruit oil, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, methylparaben, polysorbate 60, steareth-2, steareth-21, water

    Child-resistant packaging. Close cap tightly after use.

    Keep carton as it contains important information.

  • Principal Display Panel

    MAX STRENGTH
    Aspercreme
    WITH 4% LIDOCAINE
    infused with ESSENTIAL OIL
    2.5 fl oz (73 mL)

    Principal Display Panel NEW MAX STRENGTH Aspercreme WITH 4% LIDOCAINE infused with ESSENTIAL OIL 2.5 fl oz (73 mL)

  • INGREDIENTS AND APPEARANCE
    ASPERCREME LIDOCAINE NO-MESS BERGAMOT ORANGE 
    lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0590
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0590-01 in 1 CARTON01/20/2020
    173 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/20/2020
    Labeler - Chattem, Inc. (003336013)
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