1168- 1168 burn spray spray 
Dynarex Corporation

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1168 Burn Spray

Active Ingredient

Lidocaine Hydrochloride 2%

Purpose

Topical Analgesic

Use(s)

For the temporary relief of pain associated with minor burns

Warnings

For External Use Only

Do not use

• Over large areas of the body, particularly over raw surfaces, or blistered areas

• Near eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years of age and older: Spray an even layer of burn spray over cleaned, affected area not more than 3 to 4 times daily.

Children under 12 years of age: Consult a doctor before use

Other Information

• Store at 20º-25ºC (68º-77°F)

Inactive Ingredients

Glycerin, Hydroxypropyl Methyl Cellulose, Melaleuca Alterniflia (Tea Tree) Leaf Oil, Octoxynol 9, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Triethanolamine

Questions?

1-888-Dynarex Monday - Friday, 9AM - 5PM EST

Label

1168_IN_MASTER1168 Label

1168 
1168 burn spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)  
WATER (UNII: 059QF0KO0R)  
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TROLAMINE (UNII: 9O3K93S3TK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
Color    Score    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-013-0524 in 1 CASE02/29/2024
1NDC:67777-013-0659.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/29/2024
Labeler - Dynarex Corporation (008124539)

Revised: 2/2024
Document Id: 1183a4f5-f876-dfb0-e063-6394a90af35f
Set id: 1183a4f5-f875-dfb0-e063-6394a90af35f
Version: 1
Effective Time: 20240216
 
Dynarex Corporation