ASSURED  BIKINI SMOOTH CREAM- lidocaine cream 
Zhejiang Jingwei Pharmaceutical Co., Ltd.

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Drug Facts

Active Ingredients

Lidocaine 2.00 %

Purpose

Topical analgesic

   temporarily relieves pain, itching and irritation. Uses

Warnings

. For external use only

Do not use

-before any hair removal process that involves heat or lasers

-in large quantities, particularly over raw surfaces or

blistered areas

When using this product

-avoid contact with eyes   -use only as directed

Stop use and ask a doctor if

-symptoms persist for more than 7 days or clear up and occur

again within a few days

-condition worsens

-redness is present

-irritation develops

. In case of accidental ingestion, get Keep out of reach of children

medical help or contact a Poison Control Center right away.

Directions

adults and children over 12 years of age:

-immediately after hair removal, apply sparingly and only to the

areas where it is needed

-Repeat as necessary, but no more than 4 times daily

-Continue to apply as a regular part of your hair removal routine,

whether you use a razor, wax or depilatory

   store at room temperature 59 - 86 F Other information

(15 - 30 C)

  aloe barbadensis leaf juice, carbomer Inactive Ingredients

940, ethyl alcohol, ethylparaben, glycerin, menthol, propanediol,

triethanolamine, water

copy of label

ASSURED   BIKINI SMOOTH CREAM
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYLPARABEN (UNII: 14255EXE39)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
MALONDIALDEHYDE (UNII: 4Y8F71G49Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55621-011-011 in 1 BOX10/30/2015
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01510/30/2015
Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)

Revised: 10/2023
Document Id: 0884bc8d-70c2-80db-e063-6294a90a6582
Set id: fb9ddde3-3f40-467e-8aff-26570144f0fc
Version: 4
Effective Time: 20231025
 
Zhejiang Jingwei Pharmaceutical Co., Ltd.