Burn by HART Health BURN- lidocaine spray

Burn by

Drug Labeling and Warnings

Burn by is a Otc medication manufactured, distributed, or labeled by HART Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Lidocaine HCL 2%

PURPOSE

Purpose:

Topical Anesthetic

INDICATIONS & USAGE

Uses:

Temporary pain relief of minor burns

WARNINGS

Warnings

For external use only

See a doctor immediately or serious burns

Do not use

• in or near the eyes
• over large portions of the body
• in large quantities particularly over raw surfaces or blistered areas
• on serious burns
• longer than 7 days unless directed by a doctor

Stop use and ask a doctor if

• condition worsens
• condition lasts for more than 7 days
• symptoms 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 right away. 1-800-222-1222

DOSAGE & ADMINISTRATION

Directions:

Adults and children 12 years of age and over:

• clean the affected area
• apply to the affected area not more than 3 to 4 times dailys
• may be covered with a sterile bandage when dry

Children under 12 years of age: ask a doctor

OTHER SAFETY INFORMATION

store at 68° to 77°F (20-25°C)

INACTIVE INGREDIENT

Inactive Ingredients

aloe vera, germaben II, propylene glycol, purified water 

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN 
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0210-1	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2024

Labeler - HART Health (069560969)

Registrant - HART Health (069560969)