49314-0002-1 unishield first aid burn spray

49314-0002-1 unishield first aid burn spray
SPL v2
SPL
SPL Set ID f729c557-da4b-3fb5-e053-6394a90a4196
Route
topical
Published
Effective Date 2025-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
hypromelloses water glycerin tea tree oil polyoxyl 40 hydrogenated castor oil phenoxyethanol propylene glycol trolamine octoxynol 9

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-03-20
Purpose

.Topical pain relief

Description

Lidocaine HCL 2.0%

Medication Information

Warnings

For external use only

Uses

Temporary pain relief associated with minor burns

Purpose

.Topical pain relief

Directions
  • spray an over layer of burn spray over cleaned affected area not more than 3-4 times daily
  • not to be used on children under 12 years of age
Inactive Ingredients

glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

Description

Lidocaine HCL 2.0%

Do Not Use
  • in large quantities, particularly over raw or blistered areas.
  • near eyes, if this happens rinse thoroughly with water
Active Ingredient

Lidocaine HCL 2.0%

Questions Or Comments？

1-800-480-5855

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 a Poison Control Center right away.

Package Label Principal Display Panel

Structured Label Content

Warnings

For external use only

Uses

Temporary pain relief associated with minor burns

Purpose

.Topical pain relief

Directions
  • spray an over layer of burn spray over cleaned affected area not more than 3-4 times daily
  • not to be used on children under 12 years of age
Inactive Ingredients (Inactive ingredients)

glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

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 Ingredient (Active ingredient)

Lidocaine HCL 2.0%

Questions Or Comments？ (Questions or comments？)

1-800-480-5855

Stop Use and Ask A Doctor (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:06.696654 · Updated: 2026-03-14T23:10:19.800513