Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c2b84d0e-1a6c-4468-bd40-b14f30f28b79
Route
TOPICAL
Published
Effective Date 2013-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Vera Leaf Propylene Glycol Propylparaben Methylparaben Diazolidinyl Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-07-25

Description

Lidocaine HCl 2.0%

Purpose

Topical pain relief


Medication Information

Purpose

Topical pain relief

Description

Lidocaine HCl 2.0%

Uses

Temporary pain relief for minor burns

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 doctor if 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

Principal Display Panel – 2 Fl. Oz Bottle Label

The Provision

First Aid

Line™

First Aid

Burn Spray

For Temporary

Pain Relief of

Minor Burns

2 fl. oz. (59.1 ml)

Reorder no. 3500


Structured Label Content

Uses

Temporary pain relief for minor burns

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 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 (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

Principal Display Panel – 2 Fl. Oz Bottle Label (Principal Display Panel – 2 fl. oz Bottle Label)

The Provision

First Aid

Line™

First Aid

Burn Spray

For Temporary

Pain Relief of

Minor Burns

2 fl. oz. (59.1 ml)

Reorder no. 3500


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)