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Assured by Anhui NHU Pharmaceutical Co., Ltd.

Medically reviewed on Jan 29, 2018

Dosage form: gel
Ingredients: LIDOCAINE HYDROCHLORIDE 2.5g in 100g
Labeler: Anhui NHU Pharmaceutical Co., Ltd.
NDC Code: 69571-001

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,

benzalkonium chloride, carbomer 940, glycerin, menthol,

polysorbate 80, propylene glycol, sodium hydroxide, water

Active Ingredient

Lidocaine hydroxide 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 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 over 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 under 2 years of age; consult a physician

Other Information

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

ASSURED  
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
BENZALKONIUM CHLORIDE 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
GLYCERIN 
MENTHOL, UNSPECIFIED FORM 
POLYSORBATE 80 
PROPYLENE GLYCOL 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:69571-001-021 TUBE (TUBE) in 1 BOX
1NDC:69571-001-0120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/28/2015
Labeler - Anhui NHU Pharmaceutical Co., Ltd. (530897792)
Establishment
NameAddressID/FEIOperations
Anhui NHU Pharmaceutical Co., Ltd.530897792manufacture(69571-001)

 
Anhui NHU Pharmaceutical Co., Ltd.

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Further information

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

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