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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 gel 
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 WATER (AQUA), SD ALCOHOL 23-A, HEXYLENE GLYCOL, PVM/MA DECADIENE CROSSPOLYMER, SALICYLIC ACID, BENZYL ALCOHOL, PPG-2-ISODECETH-12, SODIUM HYDROXIDE, LACTIC ACID, CAMPHOR, MENTHOL, DISODIUM EDTA, DMDM HYDANTOIN.

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 061543-1604                         Guaranteed Results                
                                                                 #1604-01K


                                                             Bikini Zone

                                                      MEDICATED GEL

Bikini Zone Medicated Gel 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

Mfd. in the USA for: CCA Industries, Inc., E. Rutherford, NJ 07073 USA
1604-01K           1-800-595-6230                           BZ-R-NA

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

1604A 03-3A       1-800-595-6230        BZ-U-NA

                                                   NDC 061543-1604

Bikini Zone
                 Medicated GEL
Lidocaine - Topical Analgesic

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 Gel Tube

MEDICATED GEL

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
GEL

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

Mfd. in the USA for: CCA Industries, Inc., E. Rutherford, NJ 07073 USA
1604-01K                  1-800-595-6230                    BZ-R-NA

BikiniZone

Medicated
GEL

Bikini Zone Gel Outer

BIKINI ZONE MEDICATED 28 G 
lidocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61543-1604
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
WATER  
HEXYLENE GLYCOL  
SALICYLIC ACID  
BENZYL ALCOHOL  
SODIUM HYDROXIDE  
LACTIC ACID  
CAMPHOR (SYNTHETIC)  
MENTHOL  
EDETATE DISODIUM  
DMDM HYDANTOIN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61543-1604-1 1 TUBE ( TUBE) in 1 BOX contains a TUBE
1 28 g in 1 TUBE This package is contained within the BOX (61543-1604-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 06/04/2010

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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