GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE- benzalkonium chloride, lidocaine cream 
Yuyao Jessie Commodity Co.,Ltd.

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.

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Active Ingredient

Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%

Purpose

Purpose: First aid antiseptic, external analgesic

Use

First aid to help prevent infection and for the temporary relief of pain and itching associated with:

Minor Cuts

Scrapes

Burns

WARNINGS

keep out of reach of children

Keep out of reach of children.

If ingested,contact a poison control center right away.

Directions

Inactive ingredients

Peregal-O

Glycerin monostearate

Glycerol

Purified Water.

1

GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE 
benzalkonium chloride, lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-904
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51414-904-010.5 g in 1 PACKET; Type 0: Not a Combination Product01/05/2018
2NDC:51414-904-020.9 g in 1 PACKET; Type 0: Not a Combination Product01/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/20/2016
Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
Establishment
NameAddressID/FEIBusiness Operations
Yuyao Jessie Commodity Co.,Ltd.529892305manufacture(51414-904)

Revised: 1/2018
Document Id: 6207329a-5211-cbcf-e053-2a91aa0a719d
Set id: 29eda0ab-2109-049a-e054-00144ff88e88
Version: 3
Effective Time: 20180105
 
Yuyao Jessie Commodity Co.,Ltd.