Unburn Spray

Unburn Spray
SPL v2
SPL
SPL Set ID 40164231-1556-4714-9e27-9d41e3c71447
Route
TOPICAL
Published
Effective Date 2014-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Caprylic Alcohol Carbomer Homopolymer Type C Chlorphenesin Edetate Disodium Glyceryl Monostearate Octoxynol-9 Polysorbate 20 Phenoxyethanol Water Spearmint Oil Tea Tree Oil Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-02-01
Description

Lidocaine HCl 2.5%

Purpose

External analgesic

Medication Information

Purpose

External analgesic

Description

Lidocaine HCl 2.5%

Uses

for the temporary relief of pain associated with:

  • sunburn
  • minor burns
  • minor skin irritations
  • insect bites
Section 53413-1

[email protected]   www.waterjel.com

Warnings

For external use only

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor
Do Not Use
  • in large quantities, particularly over raw surfaces or blistered areas
Active Ingredient

Lidocaine HCl 2.5%

Other Information
  • store at 15 o to 25 oC (59 o to 77 oF)
  • do not freeze
  • you may report a serious adverse reaction to this product to 1-800-275-3433

Inactive Ingredients

acrylates/C20-30 alkyl acrylate crosspolymer, aloe, caprylyl glycol, carbomer, chlorophenesin, edetate disodium, glyceryl-7 stearate,  octoxynol-9, polysorbate 20, phenoxyethanol, purified water, spearmint oil, tea tree oil, trolamine, vitamin E acetate

Principle Display Panel

When Using This Product
  • avoid contact with eyes

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days

Keep Out of the Reach of Children

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

Structured Label Content

Uses

for the temporary relief of pain associated with:

  • sunburn
  • minor burns
  • minor skin irritations
  • insect bites
Section 53413-1 (53413-1)

[email protected]   www.waterjel.com

Purpose

External analgesic

Warnings

For external use only

Directions
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor
Do Not Use (Do not use)
  • in large quantities, particularly over raw surfaces or blistered areas
Active Ingredient (Active ingredient)

Lidocaine HCl 2.5%

Other Information (Other information)
  • store at 15 o to 25 oC (59 o to 77 oF)
  • do not freeze
  • you may report a serious adverse reaction to this product to 1-800-275-3433

Inactive Ingredients (Inactive ingredients)

acrylates/C20-30 alkyl acrylate crosspolymer, aloe, caprylyl glycol, carbomer, chlorophenesin, edetate disodium, glyceryl-7 stearate,  octoxynol-9, polysorbate 20, phenoxyethanol, purified water, spearmint oil, tea tree oil, trolamine, vitamin E acetate

Principle Display Panel

When Using This Product (When using this product)
  • avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days

Keep Out of the Reach of Children (Keep out of the reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:26.771944 · Updated: 2026-03-14T22:54:55.117494