ASSURED- lidocaine hydrochloride gel 
Zhejiang Jingwei Pharmaceutical Co., Ltd.

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Drug Facts

Inactive Ingredients  aloe barbadensis leaf juice, carbomer 940,

glycerin, menthol, methylparaben, polyethylene glycol 400,

propylene glycol, propylparaben, triethanolamine, water

Active Ingredient

Lidocaine hydrochloride 2.5 %

Purpose

Topical analgesic

Uses  for temporary relief of pain associated with

- minor burns

- sunburn

- minor cuts or scrapes

- minor skin irritations

Warnings

For external use only

Do not use

- in large quantities, particularly over raw surfaces

or blistered areas

When using this product

- avoid contact with eyes

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. If swallowed, get medical help

or contact a Poison Control Center right away

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

Other Information

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

copy of label

ASSURED 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55621-010-011 in 1 BOX10/30/2014
120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/30/2014
Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Jingwei Pharmaceutical Co., Ltd.530876549manufacture(55621-010)

Revised: 10/2023
Document Id: 0884b4eb-7fc4-b2c7-e063-6294a90aa02e
Set id: ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c
Version: 4
Effective Time: 20231025
 
Zhejiang Jingwei Pharmaceutical Co., Ltd.