ce9f2aff-6b2a-4193-8046-dac0af0bb5f1

SPL v3
SPL
SPL Set ID ce9f2aff-6b2a-4193-8046-dac0af0bb5f1
Route
topical
Published
Effective Date 2015-11-06
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 not final active Since 2014-10-06

Purpose

Topical pain relief

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses

temporary pain relief associated with minor burns

Purpose

Topical pain relief

Directions
  • adults and children 2 years of age and older: spray an even layer of burn spray over affected area not more than 3-4 times daily
  • for children under 2 years of age: consult a physician
Inactive Ingredients

aloe vera, germaben II, propylene glycol, purified water

Description

Drug Facts

Questions?

call 203-857-5361

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 doctor if condition worsens or persists for more than 7 days or clears up and returns

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%

Principal Display Panel Bottle Label

13-040

BURNS

FIRST AID ONLY ®

Burn Spray

Pain relieving spray

for use on minor burns

4 fl oz (118.3ml)


Structured Label Content

Warnings

For external use only

Uses

temporary pain relief associated with minor burns

Purpose

Topical pain relief

Directions
  • adults and children 2 years of age and older: spray an even layer of burn spray over affected area not more than 3-4 times daily
  • for children under 2 years of age: consult a physician
Inactive Ingredients (Inactive ingredients)

aloe vera, germaben II, propylene glycol, purified water

Questions?

call 203-857-5361

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 doctor if condition worsens or persists for more than 7 days or clears up and returns

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 (Active ingredient)

Lidocaine HCl 2.0%

Principal Display Panel Bottle Label (Principal Display Panel - Bottle Label)

13-040

BURNS

FIRST AID ONLY ®

Burn Spray

Pain relieving spray

for use on minor burns

4 fl oz (118.3ml)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)