SPL v1
SPL
SPL Set ID aebcfa2a-fdd8-4118-abe3-c8579a614cc7
Route
TOPICAL
Published
Effective Date 2019-10-07
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 2019-10-07

Description

Drug Facts

Purpose

Topical pain relief


Medication Information

Purpose

Topical pain relief

Description

Drug Facts

Uses

Temporary pain relief for 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

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
Questions?

call 1-800-480-5855

Active Ingredients

Lidocaine HCl 2.0%

Inactive Ingredients

aloe vera, germaben II, propylene glycol, purified water

Principal Display Panel 59.1 Ml Bottle Label

UniShield

FIRST AID

BURN

SPRAY

For Temporary

Pain Relief of

Minor Burns

NET CONTENTS 2 FL.OZ. (59.1 ML)

Distributed by: UniShield, San Fernando, CA 91340

Made in USA


Structured Label Content

Uses

Temporary pain relief for 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

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
Questions?

call 1-800-480-5855

Active Ingredients (Active ingredients)

Lidocaine HCl 2.0%

Inactive Ingredients (Inactive ingredients)

aloe vera, germaben II, propylene glycol, purified water

Principal Display Panel 59.1 Ml Bottle Label (Principal Display Panel - 59.1 mL Bottle Label)

UniShield

FIRST AID

BURN

SPRAY

For Temporary

Pain Relief of

Minor Burns

NET CONTENTS 2 FL.OZ. (59.1 ML)

Distributed by: UniShield, San Fernando, CA 91340

Made in USA


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)