aebcfa2a-fdd8-4118-abe3-c8579a614cc7

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

Purpose

Topical pain relief

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses

Temporary pain relief for minor burns

Purpose

Topical pain relief

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
Inactive Ingredients

aloe vera, germaben II, propylene glycol, purified water

Description

Drug Facts

Questions?

call 1-800-480-5855

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 Ingredients

Lidocaine HCl 2.0%

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

Warnings

For external use only

Uses

Temporary pain relief for minor burns

Purpose

Topical pain relief

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
Inactive Ingredients (Inactive ingredients)

aloe vera, germaben II, propylene glycol, purified water

Questions?

call 1-800-480-5855

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 Ingredients (Active ingredients)

Lidocaine HCl 2.0%

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

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