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:

Label

BIKINI ZONE MEDICATED CREME
lidocaine cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	06/03/2010

Labeler - CCA Industries, Inc. (106771041)

Bikini Zone Medicated CREME