First Aid Burn: Package Insert and Label Information

FIRST AID BURN- lidocaine hydrochloride spray
Unishield

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief for minor burns

Warnings

For external use only

Do not use

  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water

Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns

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

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

Questions?

call 1-800-480-5855

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

Principal Display Panel -- 59.1 mL Bottle Label
(click image for full-size original)
FIRST AID BURN
lidocaine hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-5100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride (lidocaine) Lidocaine Hydrochloride Anhydrous 20 g in 1000 mL
Inactive Ingredients
Ingredient Name Strength
aloe vera leaf
propylene glycol
diazolidinyl urea
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49314-5100-4 59.1 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 10/07/2019
Labeler — Unishield (790677053)

Revised: 10/2019 Unishield

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