61010-5100, Burn Spray

Drug Facts

Composition & Product

Inactive Ingredients

Aloe Vera Leaf Propylene Glycol Diazolidinyl Urea Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2011-08-02

Medication Information

Purpose

Topical pain relief

Description

Drug Facts

Uses

Temporary pain relief for minor burns

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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

Warnings

For external use only

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

Do Not Use

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

Active Ingredients

Lidocaine HCl 2.0%

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.

----------

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 – 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 – 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

Structured Label Content

Uses

Temporary pain relief for minor burns

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Purpose

Topical pain relief

Warnings

For external use only

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

Do Not Use (Do not use)

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

Active Ingredients (Active ingredients)

Lidocaine HCl 2.0%

Inactive Ingredients (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.

----------

Principal Display Panel – 2 Oz. Bottle (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 – 3 Oz. Bottle (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 – 4 Oz. Bottle (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

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIAZOLIDINYL UREA", "unii": "H5RIZ3MPW4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporary pain relief for minor burns", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away", "50566-9": "Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns", "Purpose": "Topical pain relief", "Warnings": "For external use only", "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", "Do not use": "in large quantities, particularly over raw or blistered areas near eyes, if this happens rinse thoroughly with water", "Active ingredients": "Lidocaine HCl 2.0%", "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. ----------", "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 – 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 – 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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information