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Assured by Zhejiang Jingwei Pharmaceutical Co., Ltd.

Dosage form: gel
Ingredients: LIDOCAINE HYDROCHLORIDE 2.5g in 100g
Labeler: Zhejiang Jingwei Pharmaceutical Co., Ltd.
NDC Code: 55621-010

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.

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 )

ASSURED 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)  
PROPYLENE GLYCOL 
TROLAMINE 
POLYETHYLENE GLYCOLS 
GLYCERIN 
MENTHOL, UNSPECIFIED FORM 
METHYLPARABEN 
PROPYLPARABEN 
ALOE VERA LEAF 
WATER 
Packaging
#Item CodePackage Description
1NDC:55621-010-011 TUBE (TUBE) in 1 BOX
120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/30/2014
Labeler - Zhejiang Jingwei Pharmaceutical Co., Ltd. (530876549)
Establishment
NameAddressID/FEIOperations
Zhejiang Jingwei Pharmaceutical Co., Ltd.530876549manufacture(55621-010)

 
Zhejiang Jingwei Pharmaceutical Co., Ltd.

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Medically reviewed on Oct 30, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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