Label: TOPICAINE 5- lidocaine 5% gel

  • NDC Code(s): 63135-581-04, 63135-581-10, 63135-581-30
  • Packager: ESBA LABORATORIES INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 15, 2023

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

View All Sections
  • Active Ingredient

    Lidocaine 5% w/w

  • Purpose

    Topical Anesthetic

  • Uses

    For the temporary relief of pain and itching due to anorectal disorders.

  • Warnings

    For external use only

    Flammable Keep away from sparks, heat and fire. Cap tube tightly when not in use.

    When using this product

    • avoid contact with eyes
    • do not use in large quantities, particularly over raw surfaces or blistered areas
    • do not put in rectum
    • do not exceed recommended dosage unless directed by a doctor

    Stop use and ask a doctor if:

    • allergic reaction occurs
    • rectal bleeding 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.

    Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Bisabolol, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Laurate, SD Alcohol 40, Shea Butter, Simmondsia Chinensis (Jojoba) Seed Oil, Water.

  • Directions

    • When practical, clean area with mild soap and warm water and rinse thoroughly
    • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
    • Adults and children 12 years old and older: Apply externally to the affected area up to 6 times a day
    • Children under 12 years of age: consult a doctor.
  • Label on tube and outer carton

    Labeling printed on tube of Topicaine 5% 10 g

    Printed tube of Topicaine 5% 10 grams

    Outer carton of Topicaine 5% 10 g tube

    Outer carton of Topicaine 5% 10 g tubes

    Label affixed to tube of Topicaine 5 % 30 g tube

    TOP5-030 label

    Outer carton of Topicaine 5 % 30 g tube:

    Topicaine 5 30 g outer carton update

    Label affixed to tube to Topicaine 5% 113 g

    Label of tube of Topicaine 5% 113 g

  • INGREDIENTS AND APPEARANCE
    TOPICAINE 5 
    lidocaine 5% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63135-581
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 5 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 2 g  in 100 g
    BENZYL ALCOHOL (UNII: LKG8494WBH) 0.8 g  in 100 g
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) 1 g  in 100 g
    SHEA BUTTER (UNII: K49155WL9Y) 2.5 g  in 100 g
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.025 g  in 100 g
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) 0.6 g  in 100 g
    GLYCERYL LAURATE (UNII: Y98611C087) 2.5 g  in 100 g
    ALCOHOL (UNII: 3K9958V90M) 36.75 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63135-581-301 in 1 BOX04/20/2003
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:63135-581-101 in 1 BOX04/20/2003
    210 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:63135-581-04113 g in 1 TUBE; Type 0: Not a Combination Product03/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/20/200312/31/2025
    Labeler - ESBA LABORATORIES INC. (963303490)
    Registrant - ESBA LABORATORIES INC. (963303490)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESBA LABORATORIES INC.963303490manufacture(63135-581)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!