SPL v2
SPL
SPL Set ID 5a4ac4cc-015a-48e7-81f8-93a895049afd
Route
TOPICAL
Published
Effective Date 2024-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Vera Leaf Propylene Glycol Diazolidinyl Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-14
Description

Drug Facts

Purpose

Topical pain reliever

Medication Information

Purpose

Topical pain reliever

Description

Drug Facts

Uses

For the temporary relief of pain associated with minor burns.

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if condition worsens or persist for more then 7 days or clears up and returns.

Section 50567-7

When using this product avoid contact with the eyes.

Warnings

For external use only.

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: consult a doctor
Do Not Use
  • in large quantities, particularly over raw surfaces or blistered areas.
Questions?

1-866-651-3660

Mon-Fri 8:00am-5:00pm EST

Manufactured for American Safety & First Aid Osceola, IN 46561

V1_11-7-19

Active Ingredient

Lidocaine HCl 2%

Other Information
  • store at room temperature
Inactive Ingredients

Aloe vera, germaben II, propylene glycol, purified water

Principal Display Panel – Bottle Label

0671

NDC 73598-0671-1

Burn Spray

Topical Pain Relief

For Temporary Pain

Relief of Minor Burns.

American Safety

& First Aid

2 fl. Oz. (59.1 ml)

Structured Label Content

Uses

For the temporary relief of pain associated with 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 a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or persist for more then 7 days or clears up and returns.

Section 50567-7 (50567-7)

When using this product avoid contact with the eyes.

Purpose

Topical pain reliever

Warnings

For external use only.

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: consult a doctor
Do Not Use (Do not use)
  • in large quantities, particularly over raw surfaces or blistered areas.
Questions?

1-866-651-3660

Mon-Fri 8:00am-5:00pm EST

Manufactured for American Safety & First Aid Osceola, IN 46561

V1_11-7-19

Active Ingredient (Active ingredient)

Lidocaine HCl 2%

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

Aloe vera, germaben II, propylene glycol, purified water

Principal Display Panel – Bottle Label

0671

NDC 73598-0671-1

Burn Spray

Topical Pain Relief

For Temporary Pain

Relief of Minor Burns.

American Safety

& First Aid

2 fl. Oz. (59.1 ml)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:00.765233 · Updated: 2026-03-14T23:02:50.389879