LIDOCAINE HYDROCHLORIDE - lidocaine hydrochloride liquid
Safetec of America, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active Ingredients

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief for minor burns

Warnings

For external use only

Do not use

In large quantities, particularly over raw or blistered areas
near eyes, if this happens rinse thoroughly with water

Stop use and ask doctor if condition worsens or persists for more than 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

for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
for children under 2 years of age consult a physician

Inactive ingredients

aloe vera, germaben II, propylene glycol, purified water

PRINCIPAL DISPLAY PANEL – 2 oz. bottle

NDC 61010-5100-4

Safetec

First Aid
Burn Spray

For Temporary
Pain Relief of
Minor Burns

2 fl. oz. (59.1 ml)

Reorder no. 50004

LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61010-5100
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine Hydrochloride (Lidocaine)	Lidocaine Hydrochloride	200 mL in 1 L

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf
propylene glycol
propylparaben
methylparaben
diazolidinyl urea
water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:61010-5100-4	0.0591 L in 1 BOTTLE	None
2	NDC:61010-5100-5	0.118 L in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/02/2011

Labeler - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Operations
Safetec of America, Inc.		874965262	MANUFACTURE

Revised: 08/2011 Safetec of America, Inc.