58228-2893 Burn Ease Cooling Gel

58228-2893 Burn Ease Cooling Gel
SPL v1
SPL
SPL Set ID ec201ca1-efa0-4797-aec3-115647c29abd
Route
TOPICAL
Published
Effective Date 2025-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Aminomethyl Propanol Ethylhexylglycerin Maltodextrin Propylene Glycol Menthol Phenoxyethanol Water .alpha.-tocopherol Acetate Aloe Barbadensis Leaf Juice

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-17
Description

Lidocaine Hydrochloride 2%

Purpose

Topical Pain Relief

Medication Information

Purpose

Topical Pain Relief

Description

Lidocaine Hydrochloride 2%

Use(s)

Temporary pain relief associated with minor burns

Section 51945-4

Warnings

For External Use Only

Directions

Apply an even layer of burn gel over cleaned affected area not more than 3-4 times daily

Not to be used on children under 12 years of age

Do Not Use

• in large quantities, particularly over raw or blistered areas

  • Near eyes. If this happens, rinse thoroughly with water

Questions?

1-888-900-2920 8AM - 4PM PST

Active Ingredient

Lidocaine Hydrochloride 2%

Other Information

• store at 68-77F (20-25C)

  • tamper evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl propanol, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Polyethylene glycol, Phenoxyethanol, Tocopheryl Acetate, 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 a Poison Control Center (1-800-222-1222) right away.

Structured Label Content

Use(s)

Temporary pain relief associated with minor burns

Section 51945-4 (51945-4)

Purpose

Topical Pain Relief

Warnings

For External Use Only

Directions

Apply an even layer of burn gel over cleaned affected area not more than 3-4 times daily

Not to be used on children under 12 years of age

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?

1-888-900-2920 8AM - 4PM PST

Active Ingredient

Lidocaine Hydrochloride 2%

Other Information

• store at 68-77F (20-25C)

  • tamper evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl propanol, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Polyethylene glycol, Phenoxyethanol, Tocopheryl Acetate, Water

Stop Use and Ask A Doctor If (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 (1-800-222-1222) right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:02.585699 · Updated: 2026-03-14T23:10:13.362427