LIDOCAINE HYDROCHLORIDE spray

Lidocaine Hydrochloride by

Drug Labeling and Warnings

Lidocaine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Cintas First Aid & Safety, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

for the temporary pain of relief associated with minor burns

Warnings

For external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas

• near eyes, if this happens rinse thoroughly with water

Stop use and ask doctor if

• condition worsens
• symptoms persist for more than 7 days
• condition clears up and occurs again within a few days

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

Directions

• adults and children 2 years of age and older: to affected area not more than 3-4 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 or Comments?

1-800-327-2704

Principal Display Panel - Bottle Label

Burn
Spray

Lidocaine HCl 2%
Water-Soluble

Convenient pump
spray allows no-touch
application. Use as a
first aid treatment for
minor burns, scalds &
sunburn.

2 fl. oz. (59.1 mL)

Xpect®
First aid

INGREDIENTS AND APPEARANCE

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68421-5100
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 g  in 1 L

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: 68421-5100-1	0.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2013

Labeler - Cintas First Aid & Safety (056481716)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(68421-5100)