BIKINI ZONE MEDICATED CREME- lidocaine cream

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Available from:
CCA Industries, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
temporarily relieves pain and itching associated with minor skin irritation.
Authorization status:
OTC monograph final
Authorization number:
61543-1601-1

BIKINI ZONE MEDICATED CREME- 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.

----------

Bikini Zone Medicated CREME

Drug Facts

Active Ingredient

LIDOCAINE 2.00%

Purpos e

topical analgesic/anesthetic

Us e

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:

BIKINI ZONE MEDICATED CREME

lidocaine cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 1543-16 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

2 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

CAMPHO R ( NATURAL) (UNII: N20 HL7Q9 41)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

CYCLO METHICO NE 6 (UNII: XHK3U310 BA)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

HEXYLENE GLYCO L (UNII: KEH0 A3F75J)

LACTIC ACID (UNII: 33X0 4XA5AT)

MENTHO L (UNII: L7T10 EIP3A)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

O CTYLDO DECANO L (UNII: 46 1N1O6 14Y)

PO LYO XYL 10 0 STEARATE (UNII: YD0 1N19 9 9 R)

PRO PYLENE GLYCO L DICAPRYLATE (UNII: 58 1437HWX2)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

SALICYLIC ACID (UNII: O414PZ4LPZ)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 1543-16 0 1-1

1 in 1 BOX

0 3/15/20 19

1

28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333B

0 6 /0 3/20 10

Labeler -

CCA Industries, Inc. (106771041)

CCA Industries, Inc.

Revised: 3/2019

Similar products

Search alerts related to this product

View documents history

Share this information