ASSURED- lidocaine hydrochloride gel

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]

INACTIVE INGREDIENT

Inactive Ingredients  aloe barbadensis leaf juice, carbomer 940,

glycerin, menthol, methylparaben, polyethylene glycol 400,

propylene glycol, propylparaben, triethanolamine, water

ACTIVE INGREDIENT

Active Ingredient

Lidocaine hydrochloride 2.5 %

PURPOSE

Purpose

Topical analgesic

INDICATIONS & USAGE

Uses  for temporary relief of pain associated with

- minor burns

- sunburn

- minor cuts or scrapes

- minor skin irritations

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

- in large quantities, particularly over raw surfaces

or blistered areas

WHEN USING

When using this product

- avoid contact with eyes

STOP USE

Stop use and ask a doctor if

- if condition worsens, or if symptoms persist for more than 7 days

or clear up and then occur again within a few days, discontinue use

of this product and consult a physician

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions

adults and children under 2 years of age:

- clean the affected area and gently dry

- apply to the affected area not more than 3 to 4 times daily

children udner 2 years of age: consult a physician

STORAGE AND HANDLING

Other Information

store at room temperature 59 - 86 F (15 C - 30 C )

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASSURED 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55621-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55621-010-01	1 in 1 BOX	10/30/2014
1		20 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 not final	part348	10/30/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Jingwei Pharmaceutical Co., Ltd.		530876549	manufacture(55621-010)