AMERICAN SAFETY FIRST AID- lidocaine hcl spray 
Orazen Inc

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71927-012 American Safety & First Aid Burn Spray

Active ingredient

Lidocaine HCL 2%

Purpose

External analgesic

Uses

for the temporary relief of pain associated with minor burns

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 the eyes

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

Questions?

1-866-651-3660
Mon-Fri 8:00am-5:00pm EST

Package Label - Principal Display Panel

image of bottle label

AMERICAN SAFETY FIRST AID 
lidocaine hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
TEA TREE OIL (UNII: VIF565UC2G)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71927-012-0159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/03/2022
Labeler - Orazen Inc (080916640)

Revised: 1/2024
Document Id: 0efffe79-6b30-8272-e063-6294a90a8f5a
Set id: ea2f776b-dfd0-6ce4-e053-2995a90af009
Version: 2
Effective Time: 20240115
 
Orazen Inc