Label: BOTTOMS UP- lidocaine liquid

  • 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 December 15, 2017

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

View All Sections
  • ACTIVE INGREDIENT

    Lidocaine 5%

  • PURPOSE

    Anorectal

  • INDICATIONS & USAGE

    For temporary relief of pain, soreness, or burning in the perianal area.

  • WARNINGS

    • For external use only. Do not use this product with a mechanical device.
    • Certain persons can develop allergic reactions to ingredients in this product.

    If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

    • Do not exceed the daily recommended dosage
    • In case of any bleeding, discontinue use and consult a doctor.
    • Avoid contact with eyes, in case of eye contact, flush with water.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep this and all drugs out of reach of children. If swallowed, seek medical help or call a Poison Control Center right away.
    • As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
  • DOSAGE & ADMINISTRATION

    • Cleanse affected area with mild soap and water.
    • Gently dry by patting or blotting with soft cloth or tissue before application.
    • Apply externally to the affected area up to 6 times daily.
  • OTHER SAFETY INFORMATION

    • Store at room temperature 20-25°C (68-77°F).
    • Tamper-Evident: Do not use if tamper evident seal under cap is broken or missing.
  • INACTIVE INGREDIENT

    Cellulose Gum, Diazolidinyl Urea, Glycerin, Isopentyldiol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water (Aqua).

  • PRINCIPAL DISPLAY PANEL

    1031935

  • INGREDIENTS AND APPEARANCE
    BOTTOMS UP 
    lidocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69797-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE3.4 g  in 68 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69797-103-0168 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2017
    2NDC:69797-103-02186 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34612/15/2017
    Labeler - WSM Investment LLC dba Topco Sales (040346439)
    Establishment
    NameAddressID/FEIBusiness Operations
    WSM Investment LLC. Topco Sales040346439manufacture(69797-103)
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!