SPL v2
SPL
SPL Set ID f612b9ad-c654-49ea-8619-3a1322ce70a7
Route
TOPICAL
Published
Effective Date 2013-04-18
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 2013-04-18

Description

Burn Spray Pain Relief Drug Facts

Purpose

Topical pain relief


Medication Information

Purpose

Topical pain relief

Description

Burn Spray Pain Relief Drug Facts

Uses

for the temporary pain of relief associated with minor burns

Section 42229-5

Burn Spray

Pain Relief

Drug Facts

Section 50565-1

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

Section 50570-1

Do not use in large quantities, particularly over raw surfaces or blistered areas

  • near eyes, if this happens rinse thoroughly with water
Warnings

For external use only

Directions
  • adults and children 2 years of age and older: to affected area not more than 3-4 times daily
  • children under 2 years: consult a doctor
Active Ingredient

Lidocaine HCl 2.0%

Other Information
  • store at room temperature
Inactive Ingredients

aloe vera, germaben II, propylene glycol, purified water

Questions Or Comments?

1-877-973-2811

Stop Use and Ask Doctor If
  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days
Principal Display Panel – 2 Oz. Bottle

BURN

SPRAY

LIDOCAINE HCl 2%

Convenient pump

spray allows no-touch

application. Use as a

first aid treatment for

minor burns, scalds &

sunburn. Water-soluble.

2 fl. oz. (59.1 mL)



Xpect

First Aid


Structured Label Content

Uses

for the temporary pain of relief associated with minor burns

Section 42229-5 (42229-5)

Burn Spray

Pain Relief

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 50570-1 (50570-1)

Do not use in large quantities, particularly over raw surfaces or blistered areas

  • near eyes, if this happens rinse thoroughly with water
Purpose

Topical pain relief

Warnings

For external use only

Directions
  • adults and children 2 years of age and older: to affected area not more than 3-4 times daily
  • children under 2 years: consult a doctor
Active Ingredient

Lidocaine HCl 2.0%

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

aloe vera, germaben II, propylene glycol, purified water

Questions Or Comments? (Questions or Comments?)

1-877-973-2811

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days
Principal Display Panel – 2 Oz. Bottle (PRINCIPAL DISPLAY PANEL – 2 oz. bottle)

BURN

SPRAY

LIDOCAINE HCl 2%

Convenient pump

spray allows no-touch

application. Use as a

first aid treatment for

minor burns, scalds &

sunburn. Water-soluble.

2 fl. oz. (59.1 mL)



Xpect

First Aid


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)