Label: HOT AND COLD WITH LIDOCAINE PAIN RELIEVING- lidocaine hcl and 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 2, 2017

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  • Drug Facts

    HOT AND COLD CREAM with LIDOCAINE

    PAIN RELIEVING CREAM

    Drug Facts

  • Active Ingredients

    Lidocaine HCl 4%

    Menthol 1%

  • Purposes

    Lidocaine- 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 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 label
    • rare cases of serious burns have been reported with products of this type
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
    • avoid contact with eyes and mucous membranes
    • a transient burning sensation may occur upon application but generally disappears in several days

    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
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

    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
    • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

    children 12 years or younger: ask a doctor

  • Inactive ingredients

    Butylated hydroxyl toluene,cetostearyl alcohol,cetomacrogol 1000,cetyl alcohol,disodium EDTA,disodium hydrogen phosphate,light liquid paraffin,propylene glycol,sorbic acid,transquitol P, white petroleum jelly

    Keep Carton As It Contains Important Information

    Close cap tightly between uses.

  • PRINCIPAL DISPLAY PANEL

    Hot and cold Cream
    Lidocaine
    Plus Menthol
    Pain Relieving Cream
    Net Wt 2.7 OZ (76.5 g)

    Icyhot cream 2.7oz

    Hot and cold Cream
    Lidocaine
    Plus Menthol
    Pain Relieving Cream
    Net Wt 1 OZ (28.35 g) ICyhot cream 1oz

  • INGREDIENTS AND APPEARANCE
    HOT AND COLD WITH LIDOCAINE  PAIN RELIEVING
    lidocaine hcl and menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.4 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-2 (UNII: 7H8VAM7778)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBIC ACID (UNII: X045WJ989B)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-100-301 in 1 CARTON03/02/2017
    176.5 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:76168-100-331 in 1 CARTON03/02/2017
    228.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/02/2017
    Labeler - Velocity Pharma LLC (962198409)
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