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Name:Bikini Zone Medicated 28 G
Manufacturer:Cca Industries, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Bikini Zone Medicated 28 G

BIKINI ZONE MEDICATED 28 G  - lidocaine cream 
CCA Industries, Inc.

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.

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Bikini Zone Medicated 28 G

Active Ingredient                                                       Purpose

LIDOCAINE 2.00%.........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.

NDC 061543-1601                         Guaranteed Results                
Dermatologist Tested                                         #1601


                                                             Bikini Zone

                                                      MEDICATED CREME

Bikini Zone Medicated Creme is specially formulated to provide fast relief from the bumps, irritation and pain that occurs in the sensitive bikini area after shaving, waxing or depilating. Bikini Zone absorbs instantly as you apply it. You’ll start to feel relief from the irritation, redness, pain and itching immediately. Bikini Zone also works to smooth away the appearance of embarrassing bumps. Plus, Bikini Zone will not stain lingerie, swimsuits or clothing. Use Bikini Zone all year long to keep your bikini area skin irritation free and beautifully smooth. For fast and easy hair removal, try new Bikini Zone Wax Strips, Creme Hair Remover and Microwave Wax. They’re specially designed for the sensitive bikini area. For more information visit us at www.BikiniZone.com

MONEY BACK GUARANTEE
Complete details available at
www.BikiniZone.com
or call 1-800-595-6230 ext. 175

Manufactured in the USA for: CCA Industries, Inc.
200 Murray Hill Parkway, E. Rutherford, NJ 07073 USA
1601-01M 1-800-595-6230 BZ-R-BN

Manufactured in the USA for: CCA Industries, Inc., E. Rutherford, NJ 07073 USA

1601A 03-3A       1-800-595-6230        BZ-U-NA

                                                   NDC 061543-1601

Bikini Zone
                 Medicated CREME
Lidocaine - Topical Analgesic

Dermatologist Tested
NET WT 1 oz/28g
Drug Facts
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

Bikini Zone Tube

MEDICATED CREME
Dermatologist Tested

Get Rid of
Bikini Bumps

Instantly Stops Irritation
Redness and Itching

Use after shaving, depilating
and waxing—Results Guaranteed

BikiniZone

Nothing Works Faster!

BikiniZone

Medicated
CREME

NET WT 1 oz/28g

Lidocaine - Topical Analgesic
Get Rid of Bikini Bumps

MONEY BACK GUARANTEE
Complete details available at
www.BikiniZone.com
or call 1-800-595-6230 ext. 175

Manufactured in the USA for: CCA Industries, Inc.
200 Murray Hill Parkway, E. Rutherford, NJ 07073 USA
1601-01M 1-800-595-6230 BZ-R-BN

BikiniZone

Medicated

CREME

Bikini Zone Outer


BIKINI ZONE MEDICATED 28 G 
lidocaine cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61543-1601
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 2.00 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
CAMPHOR (NATURAL)  
CETOSTEARYL ALCOHOL  
CYCLOMETHICONE 6  
CYCLOMETHICONE 5  
EDETATE DISODIUM  
DIAZOLIDINYL UREA  
GLYCERYL MONOSTEARATE  
HEXYLENE GLYCOL  
LACTIC ACID  
MENTHOL  
METHYLPARABEN  
OCTYLDODECANOL  
POLYOXYL 100 STEARATE  
PROPYLENE GLYCOL DICAPRYLATE  
PROPYLENE GLYCOL  
PROPYLPARABEN  
SALICYLIC ACID  
SODIUM HYDROXIDE  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61543-1601-1 1 TUBE ( TUBE) in 1 BOX contains a TUBE
1 28 g in 1 TUBE This package is contained within the BOX (61543-1601-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 06/03/2010

Labeler - CCA Industries, Inc. (106771041)
Establishment
Name Address ID/FEI Operations
RMJ Laboratories, Inc. 118225528 manufacture
Establishment
Name Address ID/FEI Operations
Dimensional Merchandising Inc's 076693183 manufacture
Establishment
Name Address ID/FEI Operations
WaterJel Technologies 155522589 manufacture

Revised: 06/2010 CCA Industries, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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