BIKINI ZONE MEDICATED CREME- lidocaine cream

Bikini Zone Medicated CREME by

Drug Labeling and Warnings

Bikini Zone Medicated CREME by is a Otc medication manufactured, distributed, or labeled by CCA Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

BIKINI ZONE MEDICATED CREME 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61543-1601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61543-1601-1	1 in 1 BOX	03/15/2019
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	06/03/2010

Labeler - CCA Industries, Inc. (106771041)