Label: PAIN ITCH RELIEF- lidocaine hci cream

  • NDC Code(s): 69396-120-17
  • Packager: Trifecta Pharmaceutical USA LLC
  • 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 February 6, 2023

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  • DRUG FACTS

  • Active Ingredient

    Lidocaine HCI 4%

  • Purpose

    Topical Anesthetic

  • Uses

    Temporarily relieves minor pain

  • Warnings

    For external use only.

  • When using this product

    Use only as directed.

    Do not allow contact with eyes.

    Do not bandage or apply local heat such as heating pads to the area of use

  • 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

  • If Pregnant or Breast Feeding

    Ask a health professional before 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.
  • 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

  • Questions

    For Questions please call 1 888 296 9067

  • Other Information

    Store at room temperature

  • Inactive Ingredient:

    Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl Sterate, Light Mineral Oil, Petrolatum, Polyoxyethylene Lauryl Ether, Purified Water, Sodium Lauryl Sulfate.

  • Distributed By

    Trifecta Pharmaceuticals USA

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

    This product is not manufactured or distributed by Chattem, Inc. a Sanofi Company owner of the registered trademark Gold Bond.

  • Packaging

    Globe Lidocaine Cream 49.6g CDER

  • INGREDIENTS AND APPEARANCE
    PAIN ITCH RELIEF 
    lidocaine hci cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-120
    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
    STEARETH-21 (UNII: 53J3F32P58)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CYCLOMETHICONE 7 (UNII: KCK5L8VU47)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    WATER (UNII: 059QF0KO0R)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-120-171 in 1 BOX01/06/2023
    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 finalpart34801/06/2023
    Labeler - Trifecta Pharmaceutical USA LLC (079424163)
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