ASSURED BIKINI SMOOTH CREAM- lidocaine cream

Assured by

Drug Labeling and Warnings

Assured by is a Otc medication manufactured, distributed, or labeled by Zhejiang Jingwei Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Lidocaine 2.00 %

PURPOSE

Purpose

Topical analgesic

INDICATIONS & USAGE

Uses   temporarily relieves pain, itching and irritation.

WARNINGS

Warnings

For external use only.

DO NOT USE

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

When using this product

-avoid contact with eyes   -use only as directed

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information   store at room temperature 59 - 86 F

(15 - 30 C)

INACTIVE INGREDIENT

Inactive Ingredients  aloe barbadensis leaf juice, carbomer

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

triethanolamine, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASSURED  BIKINI SMOOTH CREAM
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55621-011
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55621-011-01	1 in 1 BOX	10/30/2015
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	part346	10/30/2015

Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)