LIDOCAINE HYDROCHLORIDE liquid

Lidocaine Hydrochloride by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 a 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 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

Manufactured by SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 800-456-7077 www.safetec.com

PAIN RELIEF – Burn Spray 
Safetec of America

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.
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PRINCIPAL DISPLAY PANEL – 3 oz. bottle

NDC: 61010-5100-3

Safetec

First Aid
Burn Spray

For Temporary
Pain Relief of
Minor Burns

3 fl. oz. (88.7 ml)

Reorder no. 50104

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

PRINCIPAL DISPLAY PANEL – 4 oz. bottle

NDC: 61010-5100-5

Safetec

First Aid
Burn Spray

For Temporary
Pain Relief of
Minor Burns

4 fl. oz. (118 ml)

Reorder no. 50005

INGREDIENTS AND APPEARANCE

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-5100
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 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: 61010-5100-3	88.7 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/02/2011	04/03/2014
2	NDC: 61010-5100-4	59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/02/2011
3	NDC: 61010-5100-5	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/02/2011

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	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(61010-5100)