61010-5100, Burn Spray

Label at a glance#

Contacts and useful links#

PhoneLabel contact800-456-7077

Websitewww.safetec.comwww.safetec.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 2.0%

Purpose

OTC - PURPOSE SECTION

Topical pain relief

Uses

INDICATIONS & USAGE SECTION

Temporary pain relief for minor burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctorif condition worsens or persists for more than 7 days or clears up and returns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-5100-5

Safetec

First Aid
Burn Spray

For Temporary
Pain Relief of
Minor Burns

4 fl. oz. (118 ml)

Reorder no. 50005

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

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FDA-Initiated Inactive NDC Indexing#

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DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

• Lidocaine Hydrochloride
• ALOE VERA LEAF
• PROPYLENE GLYCOL
• DIAZOLIDINYL UREA
• WATER
• LIDOCAINE
• LIDOCAINE HYDROCHLORIDE ANHYDROUS

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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Inactive ingredient links page 1 of 2 · 78 matching rows.

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Matched openFDA labels page 1 of 1 · 1 matching rows.

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Adverse event summaries are temporarily unavailable. Other product information remains available.