96f17095-31f3-4b8a-ab22-0caaefaa7476

SPL v3
SPL
SPL Set ID 96f17095-31f3-4b8a-ab22-0caaefaa7476
Route
topical
Published
Effective Date 2015-09-03
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 2013-05-01

Purpose

Topical pain relief

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses

for the temporary pain of relief associated with minor burns

Purpose

Topical pain relief

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
Other Information
  • store at room temperature
Inactive Ingredients

aloe vera, germaben II, propylene glycol, purified water

Description

Drug Facts

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.

Do Not Use

in large quantities, particularly over raw surfaces or blistered areas

  • near eyes, if this happens rinse thoroughly with water
Active Ingredient

Lidocaine HCl 2.0%

Questions Or Comments?

1-800-327-2704

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 Bottle Label

Burn

Spray

Lidocaine HCl 2%

Water-Soluble

Convenient pump

spray allows no-touch

application. Use as a

first aid treatment for

minor burns, scalds &

sunburn.

2 fl. oz. (59.1 mL)

Xpect ®

First aid


Structured Label Content

Warnings

For external use only

Uses

for the temporary pain of relief associated with minor burns

Purpose

Topical pain relief

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

aloe vera, germaben II, propylene glycol, purified water

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.

Do Not Use (Do not use)

in large quantities, particularly over raw surfaces or blistered areas

  • near eyes, if this happens rinse thoroughly with water
Active Ingredient

Lidocaine HCl 2.0%

Questions Or Comments? (Questions or Comments?)

1-800-327-2704

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 Bottle Label (Principal Display Panel - Bottle Label)

Burn

Spray

Lidocaine HCl 2%

Water-Soluble

Convenient pump

spray allows no-touch

application. Use as a

first aid treatment for

minor burns, scalds &

sunburn.

2 fl. oz. (59.1 mL)

Xpect ®

First aid


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)