61010-5000, Burn Gel

SPL v5

SPL

SPL Set ID 1c5eb3b3-79b3-472a-ae36-ec6a7dc72925

Route

TOPICAL

Published

Effective Date 2020-03-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients

Aloe Vera Leaf Propylene Glycol Diazolidinyl Urea Water Menthol .alpha.-tocopherol Acetate Trolamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-09-19

Description

Pain Relief Drug Facts

Purpose

Topical pain relief

Medication Information

Purpose

Topical pain relief

Description

Pain Relief Drug Facts

Uses

Temporary pain relief for minor burns

Section 42229-5

Pain Relief

Drug Facts

Section 50566-9

Stop use and ask doctorif condition worsens or persists for more than 7 days or clears up and occurs again within a few days

Warnings

For external use only

Directions

for adults and children 2 years and older: apply to affected area not more than 4 times daily
children under 2: do not use, consult a doctor

Do Not Use

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

Active Ingredient

Lidocaine HCl 2.0%

Inactive Ingredients

aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate

Keep Out of Reach of Children.

If swallowed get medical help or contact a Poison Control Center right away

Principal Display Panel Pouch Label

Safetec

Burn Gel

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Principal Display Panel 25 Box Label

NDC 61010-5000-5

Safetec

First Aid

Burn Gel

For Temporary Pain Relief

of Minor Burns

25 Packets

Each Packet Net. Wt. 0.9gm

Principal Display Panel 144 Box Label

NDC 61010-5000-04

Safetec

First Aid

Burn Gel

For Temporary Pain Relief

of Minor Burns

Reorder No. 50007

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Principal Display Panel – 4 Oz. Bottle

NDC 61010-5000-1

Safetec

First Aid

Burn Gel

For Temporary

Pain Relief of

Minor Burns

4 fl. oz. (118 ml)

Reorder no. 50001

Principal Display Panel – 0.125 Oz. Packet

NDC 61010-5000-0

Safetec

Burn Gel

For Temporary

Pain Relief of

Minor Burns

0.125 oz. (3.7 ml)

Reorder no. 50000

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215

800-456-7077

www.safetec.com

Principal Display Panel – 10 Packet Box Label

Safetec ^®

First Aid

Burn Gel

Quickly soothes pain

caused by minor burns

10 Packets

Each Packet Net. Wt. 0.9g

Made in USA

Reorder No. 50028

Structured Label Content

Uses

Temporary pain relief for minor burns

Section 42229-5 (42229-5)

Pain Relief

Drug Facts

Section 50566-9 (50566-9)

Stop use and ask doctorif condition worsens or persists for more than 7 days or clears up and occurs again within a few days

Purpose

Topical pain relief

Warnings

For external use only

Directions

for adults and children 2 years and older: apply to affected area not more than 4 times daily
children under 2: do not use, consult a doctor

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 Ingredient

Lidocaine HCl 2.0%

Inactive Ingredients (Inactive ingredients)

aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed get medical help or contact a Poison Control Center right away

Principal Display Panel Pouch Label (Principal Display Panel - Pouch label)

Safetec

Burn Gel

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Principal Display Panel 25 Box Label (Principal Display Panel - 25 Box label)

NDC 61010-5000-5

Safetec

First Aid

Burn Gel

For Temporary Pain Relief

of Minor Burns

25 Packets

Each Packet Net. Wt. 0.9gm

Principal Display Panel 144 Box Label (Principal Display Panel - 144 Box label)

NDC 61010-5000-04

Safetec

First Aid

Burn Gel

For Temporary Pain Relief

of Minor Burns

Reorder No. 50007

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Principal Display Panel – 4 Oz. Bottle (PRINCIPAL DISPLAY PANEL – 4 oz. bottle)

NDC 61010-5000-1

Safetec

First Aid

Burn Gel

For Temporary

Pain Relief of

Minor Burns

4 fl. oz. (118 ml)

Reorder no. 50001

Principal Display Panel – 0.125 Oz. Packet (PRINCIPAL DISPLAY PANEL – 0.125 oz. packet)

NDC 61010-5000-0

Safetec

Burn Gel

For Temporary

Pain Relief of

Minor Burns

0.125 oz. (3.7 ml)

Reorder no. 50000

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215

800-456-7077

www.safetec.com

Principal Display Panel – 10 Packet Box Label

Safetec ^®

First Aid

Burn Gel

Quickly soothes pain

caused by minor burns

10 Packets

Each Packet Net. Wt. 0.9g

Made in USA

Reorder No. 50028

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": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporary pain relief for minor burns", "42229-5": "Pain Relief Drug Facts", "50566-9": "Stop use and ask doctor if condition worsens or persists for more than 7 days or clears up and occurs again within a few days", "Purpose": "Topical pain relief", "Warnings": "For external use only", "Directions": "for adults and children 2 years and older: apply to affected area not more than 4 times daily children under 2: do not use, consult a doctor", "Do not use": "In large quantities, particularly over raw or blistered areas near eyes, if this happens rinse thoroughly with water", "Active Ingredient": "Lidocaine HCl 2.0%", "Inactive ingredients": "aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate", "Keep out of reach of children.": "If swallowed get medical help or contact a Poison Control Center right away", "Principal Display Panel - Pouch label": "Safetec Burn Gel 0.9 g (1/32 oz.) Safetec of America, Inc. Buffalo, NY 14215 800-456-7077", "Principal Display Panel - 25 Box label": "NDC 61010-5000-5 Safetec First Aid Burn Gel For Temporary Pain Relief of Minor Burns 25 Packets Each Packet Net. Wt. 0.9gm", "Principal Display Panel - 144 Box label": "NDC 61010-5000-04 Safetec First Aid Burn Gel For Temporary Pain Relief of Minor Burns Reorder No. 50007 To reorder: Call: 1-800-456-7077 Fax: 716-895-2969 Online: www.safetec.com", "PRINCIPAL DISPLAY PANEL – 4 oz. bottle": "NDC 61010-5000-1 Safetec First Aid Burn Gel For Temporary Pain Relief of Minor Burns 4 fl. oz. (118 ml) Reorder no. 50001", "PRINCIPAL DISPLAY PANEL – 0.125 oz. packet": "NDC 61010-5000-0 Safetec Burn Gel For Temporary Pain Relief of Minor Burns 0.125 oz. (3.7 ml) Reorder no. 50000 Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com", "Principal Display Panel – 10 Packet Box Label": "Safetec ® First Aid Burn Gel Quickly soothes pain caused by minor burns 10 Packets Each Packet Net. Wt. 0.9g Made in USA Reorder No. 50028"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:46.129821 · Updated: 2026-03-14T23:02:29.359860