Bikini Zone Medicated Creme
FDA Label NDC 61543-1601

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cca Industries, Inc. for the product Bikini Zone Medicated Creme (NDC 61543-1601). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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 Report any issues associated with this product to the telephone number or address listed on this package.

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