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Bikini Zone Medicated CREME by CCA Industries, Inc.

Dosage form: cream
Ingredients: LIDOCAINE 2.00g in 100g
Labeler: CCA Industries, Inc.
NDC Code: 61543-1613

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.

Bikini Zone Medicated CREME

Active Ingredient

LIDOCAINE 2.00%

Purpose

TOPICAL ANALGESIC/ANESTHETIC

Use

Temporarily relieves pain, itching and irritation.

Warnings

For external use only.

When using this product
  • Use only as directed
  • Do not use before any hair removal process that involves heat or lasers
  • Avoid contact with eyes
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.

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

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

Directions

Adults and children over 12 years

  • See top of cap to open tube
  • Immediately after hair removal, apply Bikini Zone sparingly and only to the areas where it’s needed
  • Repeat as necessary, but no more than 4 times daily
  • Continue to apply Bikini Zone as a regular part of your hair removal routine, whether you use a razor, wax or depilatory.

Inactive Ingredients

WATER (AQUA), SD ALCOHOL 23A, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, OCTYLDODECANOL, CETEARYL ALCOHOL, HEXYLENE GLYCOL, LACTIC ACID, POLYQUATERNIUM-37, PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE, PPG-1 TRIDECETH-6, SALICYLIC ACID, BENZYL ALCOHOL, ALOE BARBADENSIS GEL, GLYCERYL STEARATE, PEG-100 STEARATE, PEG-40 STEARATE, CAMPHOR, MENTHOL, GLYCERYL DILAURATE, DISODIUM EDTA, SODIUM HYDROXIDE, FRAGRANCE, PROPYLENE GLYCOL, DIAZOLIDINYL UREA, METHYLPARABEN,PROPYLPARABEN.

Questions or Comments?

Call 1-800-595-6230 Report any issues associated with this product to the telephone number or address listed on this package.

Bikini Zone Medicated CREME .5oz/14g (61543-1613)



BIKINI ZONE MEDICATED CREME 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-1613
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE2.00 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
CYCLOMETHICONE 6 
OCTYLDODECANOL 
CETOSTEARYL ALCOHOL 
HEXYLENE GLYCOL 
LACTIC ACID 
PROPYLENE GLYCOL DICAPRYLATE 
SALICYLIC ACID 
BENZYL ALCOHOL 
GLYCERYL MONOSTEARATE 
POLYOXYL 100 STEARATE 
CAMPHOR (SYNTHETIC) 
MENTHOL 
EDETATE DISODIUM 
SODIUM HYDROXIDE 
PROPYLENE GLYCOL 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:61543-1613-51 TUBE (TUBE) in 1 BOX
114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B06/04/2010
Labeler - CCA Industries, Inc. (106771041)
Establishment
NameAddressID/FEIOperations
Suite K Value Added Services LLC036822144manufacture(61543-1613)

Revised: 08/2013
 
CCA Industries, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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