Label: BIKINI ZONE MEDICATED CREME- lidocaine cream

  • 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 16, 2022

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

View All Sections
  • Drug Facts

  • Active Ingredient

    LIDOCAINE 2.00%

    Purpose

    topical analgesic/anesthetic

  • Use

    temporarily relieves pain and itching associated with minor skin irritation.

  • Warnings

    For external use only.

    Avoid contact with eyes

    Do not use 

    • in large quantities, particularly over raw surfaces or blistered areas.
    • before any hair removal process that involves heat or lasers

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms last for more than 7 days or clear up and occur again within a few days.
    • redness is present
    • irritation develops

    Keep out of reach of children

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 12 years and older

    • see top of cap to open tube
    • immediately after hair removal, apply sparingly to areas affected
    • repeat as necessary, but no more than 4 times daily
    • continue to apply as a part of your hair removal routine, whether you use a razor, wax or depilatory.
    • children under 2 years: ask a doctor
  • Other information

    store at room temperature 15°-30°C (59°-86°F)

  • Inactive Ingredients

    aloe barbadensis gel, benzyl alcohol, camphor, cetearyl alcohol, cyclohexasiloxane, cyclopentasiloxane, disodium edta, diazolidinyl urea, fragrance, glyceryl dilaurate, glyceryl stearate, hexylene glycol, lactic acid, menthol, methylparaben, octyldodecanol, peg-40 stearate, peg-100 stearate, polyquaternium-37, ppg-1 trideceth-6, propylene glycol dicaprylate/dicaprate, propylene glycol, propylparaben, salicylic acid, sd alcohol 23a, sodium hydroxide, water (aqua).

  • Questions or Comments?

     Call 1-800-595-6230 

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    BIKINI ZONE MEDICATED CREME 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-1601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61543-1601-11 in 1 BOX03/15/2019
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B06/03/2010
    Labeler - CCA Industries, Inc. (106771041)
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!