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

Description

Drug Facts

Purpose

Topical pain relief


Medication Information

Purpose

Topical pain relief

Description

Drug Facts

Uses

for the temporary pain of relief 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 Poison Control Center right away.

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
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%

Other Information
  • store at room temperature
Inactive Ingredients

aloe vera, germaben II, propylene glycol, purified water

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

Uses

for the temporary pain of relief 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 Poison Control Center right away.

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
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%

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?)

1-800-327-2704

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)