FIRST AID BURN CREAM- lidocaine cream 
Davemed Healthcare 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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First Aid Burn Cream

Active Ingredients

Active Ingredient

Lidocaine HCL 0.5%

Benzalkonium Chloride 0.13%

Purpose

First aid antiseptic, external analgesic

Temporary relief of pain associated with minor burns

Uses

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns.

EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

If ingested, get medical help or contact a Poison Control Center right away.

DO NOT USE

DO NOT USE:

Directions

Inactive ingredients

inactive ingredient

Other Information

Other Information

Store at room temperature

Principal Display Panel

label

FIRST AID BURN CREAM 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70897-001
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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
MINERAL OIL (UNII: T5L8T28FGP)  
METHYL PARAOXON (UNII: UE1A2XL95H)  
PETROLATUM (UNII: 4T6H12BN9U)  
DIISOPROPYL PARAOXON (UNII: R90A2849YV)  
ALLANTOIN (UNII: 344S277G0Z)  
TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)  
STEARIC ACID D7 (UNII: T3B081197X)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70897-001-010.9 g in 1 BAG; Type 0: Not a Combination Product08/11/2016
2NDC:70897-001-0242.5 g in 1 BAG; Type 0: Not a Combination Product08/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/09/2016
Labeler - Davemed Healthcare Co., Ltd (529128716)
Establishment
NameAddressID/FEIBusiness Operations
Davemed Healthcare Co., Ltd529128716manufacture(70897-001)

Revised: 2/2020
Document Id: 9db29e83-9948-14af-e053-2995a90ac698
Set id: 39a4f401-9fae-2e1a-e054-00144ff88e88
Version: 4
Effective Time: 20200203
 
Davemed Healthcare Co., Ltd