Drug Facts

Active ingredient

Lidocaine HCl 2%

Purpose

Topical pain reliever

For the temporary relief of pain associated with minor burns.

For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if condition worsens or persist for more then 7 days or clears up and returns.

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

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years: consult a doctor

Aloe vera, germaben II, propylene glycol, purified water

1-866-651-3660

Mon-Fri 8:00am-5:00pm EST

Manufactured for American Safety & First Aid Osceola, IN 46561

V1_11-7-19

0671

NDC 73598-0671-1

Burn Spray

Topical Pain Relief

For Temporary Pain
Relief of Minor Burns.

American Safety
& First Aid

2 fl. Oz. (59.1 ml)

BURN
lidocaine hydrochloride spray

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	Lidocaine Hydrochloride Anhydrous	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
aloe vera leaf (UNII: ZY81Z83H0X)
propylene glycol (UNII: 6DC9Q167V3)
diazolidinyl urea (UNII: H5RIZ3MPW4)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73598-0671-1	59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M017	02/14/2020

Labeler - JHK Inc (867236309)

Registrant - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(73598-0671)