Label: 4 LIDOCAINE TOPICAL ANESTHETIC- lidocaine 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 April 7, 2020

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  • Drug Facts

  • Active ingredient

    Active ingredient

    Purpose

    Topical Analgesic

  • Uses

    temporarily relieves pain and itching due to:

    • minor cuts
    • minor scrapes
    • sunburn
    • minor skin irritations
    • minor burns
    • insect bites
  • Warnings

    For external use only.

    When using this product

    • do not use in or near the eyes
    • do not use in large quantities, particularly over raw surfaces or blistered areas.

    Stop use and ask a doctor if

    • Allergic reaction occurs
    • condition worsens or does not improve within 7 days
    • symptoms clear up and return within a few days
    • redness, irritation, swelling, pain or other symptoms begin or increase

    Do not apply over large areas of the body.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
    • Children under 2 years: Consult a doctor.
  • Other information

    • Store at USP controlled room temperature 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    aloe barbadensis leaf extract, benzyl alcohol, carbomer 940, cetyl alcohol, cholesterol, di-alpha tocopherol, glycerin, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, stearic acid, trolamine

  • Questions & Comments?

    1-800-645-2158

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    4 LIDOCAINE TOPICAL ANESTHETIC 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1267
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1267-2015 g in 1 BOX; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/30/2020
    Labeler - RUGBY LABORATORIES (079246066)
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