SAFLY BURN- lidocaine hydrochloride cream 
Nantong Health & Beyond Hygienic Products Inc.

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43473-039 burn cream

Active ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCI         0.5%

Purpose

First Aid Antiseptic
Topical Analgesic

Uses

Temporary relief of pain associated with minor cuts, scrapes, and burns.
Helps protect against harmful bacteria.

Warnings

For external use only.

Do not use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center directly.

Directions 

Other Information

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate/PÉG-100 Stearate, Maltodextrin, Mineral Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine.

image description

SAFLY BURN 
lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43473-039
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
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
DISODIUM HEDTA (UNII: KME849MC7A)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MINERAL OIL (UNII: T5L8T28FGP)  
TRICLOSAN (UNII: 4NM5039Y5X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43473-039-010.9 g in 1 PACKET; Type 0: Not a Combination Product05/17/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/17/2024
Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)
Establishment
NameAddressID/FEIBusiness Operations
Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(43473-039)

Revised: 5/2024
Document Id: 18a9bfd1-8c9c-ab78-e063-6394a90abdfc
Set id: 3aca2568-d10f-4b14-861b-6c741c106829
Version: 1
Effective Time: 20240517
 
Nantong Health & Beyond Hygienic Products Inc.