Label: DG HEALTH MAXIMUM STRENGTH COLD N HOT- lidocaine hcl, menthol 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 March 13, 2020

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

  • Active ingredients

    Lidocaine HCl 4%

    Menthol 1%

  • Purpose

    Lidocaine HCl - Topical anesthetic

    Menthol – Topical analgesic

  • Uses

    temporarily relieves minor pain

  • Warnings

    For external use only

    Do not use

    on large areas of the body or on cut, irritated, swollen, or blistered skin
    on puncture wounds
    for more than one week without consulting a doctor

    When using this product

    use only as directed
    do not get into eyes
    do not bandage tightly or apply external heat (such as a heating pad) to the area of use

    Stop use and ask a doctor if

    condition worsens
    symptoms persist for more than 7 days or clear up and occur again within a few days
    redness, rash, or irritation occurs
  • 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 12 years and over: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
    children under 12 years: ask a doctor
  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, bis-vinyl dimethicone/dimethicone copolymer, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, chlorphenesin, dicetyl phosphate, dimethicone, edetate disodium, glycerin, glyceryl stearate SE, phenoxyethanol, purified water, SD alcohol 40, steareth-21

  • Package/Label Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    DG HEALTH MAXIMUM STRENGTH COLD N HOT 
    lidocaine hcl, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-760
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE40 mg  in 1 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    C30-45 ALKYL METHICONE (UNII: NFX970DSI2)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    STEARETH-21 (UNII: 53J3F32P58)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-760-011 in 1 CARTON03/30/2020
    149.6 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 finalpart34803/30/2020
    Labeler - DOLGENCORP, LLC (068331990)