BURN- lidocaine hydrochloride spray

Burn by

Drug Labeling and Warnings

Burn by is a Otc medication manufactured, distributed, or labeled by JHK Inc, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Lidocaine HCl 2%

Purpose

Topical pain reliever

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 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.

Directions

• 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

Other information

• store at room temperature

Inactive ingredients

Aloe vera, germaben II, propylene glycol, purified water

Questions?

1-866-651-3660

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

Manufactured for American Safety & First Aid Osceola, IN 46561

V1_11-7-19

Principal Display Panel – Bottle Label

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)

INGREDIENTS AND APPEARANCE

BURN 
lidocaine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73598-0671
Route of Administration	TOPICAL

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

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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/14/2020

Labeler - JHK Inc (867236309)

Registrant - Safetec of America, Inc. (874965262)

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